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Writing and Editing for Biomedical

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					Uniform Requirements for Manuscripts Submitted to Biomedical
Journals: Writing and Editing for Biomedical Publication
(Updated October 2008)
Publication Ethics: Sponsorship, Authorship, and Accountability
International Committee of Medical Journal Editors

T  he following information is available to be viewed/
   printed in Adobe Acrobat pdf format.
   I. Statement of Purpose
                                                                  I. Medical Journals and the General Media
                                                                  J. Obligation to Register Clinical Trials
                                                                  IV. Manuscript Preparation and Submission
   A. About the Uniform Requirements                              A. Preparing a Manuscript for Submission to Biomed-
   B. Potential Users of the Uniform Requirements                    ical Journals
   C. How to Use the Uniform Requirements                         1. a. General Principles
   II. Ethical Considerations in the Conduct and Report-          b. Reporting Guidelines for Specific Study Designs
       ing of Research                                            2. Title page
   A. Authorship and Contributorship                              3. Conflict-of-interest Notification Page
   1. Byline Authors                                              4. Abstract and Key Words
   2. Contributors Listed in Acknowledgments                      5. Introduction
   B. Editorship                                                  6. Methods
   1. The Role of the Editor                                      a. Selection and Description of Participants
   2. Editorial Freedom                                           b. Technical Information
   C. Peer Review                                                 c. Statistics
   D. Conflicts of Interest                                        7. Results
   1. Potential Conflicts of Interest Related to Individual        8. Discussion
      Authors’ Commitments                                        9. References
   2. Potential Conflicts of Interest Related to Project           a. General Considerations Related to References
      Support                                                     b. Reference Style and Format
   3. Potential Conflicts of Interest Related to Commit-           10. Tables
      ments of Editors, Journal Staff, or Reviewers               11. Illustrations (Figures)
   E. Privacy and Confidentiality                                  12. Legends for Illustrations (Figures)
                                                                  13. Units of Measurement
   1. Patients and Study Participants
                                                                  14. Abbreviations and Symbols
   2. Authors and Reviewers
                                                                  B. Sending the Manuscript to the Journal
   F. Protection of Human Subjects and Animals in Re-
                                                                  V. References
      search
                                                                  A. Print References Cited in this Document
   III. Publishing and Editorial Issues Related to Publica-
                                                                  B. Other Sources of Information Related to Biomedi-
        tion in Biomedical Journals
                                                                     cal Journals
   A. Obligation to Publish Negative Studies                      VI. About the International Committee of Medical
   B. Corrections, Retractions, and “Expressions of Con-              Journal Editors
       cern”                                                      VII. Authors of the Uniform Requirements
   C. Copyright                                                   VIII. Use, Distribution, and Translation of the Uni-
   D. Overlapping Publications                                          form Requirements
   1. Duplicate Submission                                        IX. Inquiries
   2. Redundant Publication
   3. Acceptable Secondary Publication
   4. Competing Manuscripts based on the Same Study           I. STATEMENT   OF   PURPOSE
   a. Differences in Analysis or Interpretation               I. A. About the Uniform Requirements
   b. Differences in Reported Methods or Results                   A small group of editors of general medical journals
   5. Competing Manuscripts Based on the Same Data-           met informally in Vancouver, British Columbia, in 1978
      base                                                    to establish guidelines for the format of manuscripts sub-
   E. Correspondence                                          mitted to their journals. This group became known as the
   F. Supplements, Theme Issues, and Special Series           Vancouver Group. Its requirements for manuscripts, in-
   G. Electronic Publishing                                   cluding formats for bibliographic references developed by
   H. Advertising                                             the National Library of Medicine (NLM), were first pub-
                                                                                                                      1
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


lished in 1979. The Vancouver Group expanded and                        I. C. How to Use the Uniform Requirements
evolved into the International Committee of Medical Jour-                    The Uniform Requirements state the ethical principles
nal Editors (ICMJE), which meets annually. The ICMJE                    in the conduct and reporting of research and provide rec-
has gradually broadened its concerns to include ethical                 ommendations relating to specific elements of editing and
principles related to publication in biomedical journals.               writing. These recommendations are based largely on the
      The ICJME has produced multiple editions of the                   shared experience of a moderate number of editors and
Uniform Requirements for Manuscripts Submitted to Bio-                  authors, collected over many years, rather than on the re-
medical Journals. Over the years, issues have arisen that go            sults of methodical, planned investigation that aspires to be
beyond manuscript preparation, resulting in the develop-                “evidence-based.” Wherever possible, recommendations
ment of a number of Separate Statements on editorial pol-               are accompanied by a rationale that justifies them; as such,
icy. The entire Uniform Requirements document was re-                   the document serves an educational purpose.
vised in 1997; sections were updated in May 1999 and                         Authors will find it helpful to follow the recommen-
May 2000. In May 2001, the ICMJE revised the sections                   dations in this document whenever possible because, as
related to potential conflict of interest. In 2003, the com-             described in the explanations, doing so improves the qual-
mittee revised and reorganized the entire document and                  ity and clarity of reporting in manuscripts submitted to
incorporated the Separate Statements into the text. The                 any journal, as well as the ease of editing. At the same time,
committee prepared this revision in 2008.                               every journal has editorial requirements uniquely suited to
      The total content of the Uniform Requirements for                 its purposes. Authors therefore need to become familiar
                                                                        with the Instructions to Authors specific to the journal
Manuscripts Submitted to Biomedical Journals may be re-
                                                                        they have chosen for their manuscript—for example, the
produced for educational, not-for-profit purposes without
                                                                        topics suitable for that journal, and the types of papers that
regard for copyright; the committee encourages distribu-
                                                                        may be submitted (for example, original articles, reviews,
tion of the material.
                                                                        or case reports)—and should follow those instructions.
      Journals that agree to use the Uniform Requirements
are encouraged to state in their instructions to authors that
their requirements are in accordance with the Uniform                   II. ETHICAL CONSIDERATIONS       IN THE   CONDUCT    AND
Requirements and to cite this version. Journals that wish to            REPORTING OF RESEARCH
be listed on www.ICMJE.org as a publication that follows                II. A. Authorship and Contributorship
the Uniform Requirements should contact the ICMJE sec-                  II. A. 1. Byline Authors
retariat office.                                                              An “author” is generally considered to be someone
      The ICMJE is a small working group of general med-                who has made substantive intellectual contributions to a
ical journals, not an open-membership organization. Occa-               published study, and biomedical authorship continues to
sionally, the ICMJE will invite a new member or guest                   have important academic, social, and financial implications
when the committee feels that the journal or organization               (1). In the past, readers were rarely provided with informa-
will provide a new perspective. Open membership organi-                 tion about contributions to studies from persons listed as
zations for editors and others in biomedical publication                authors and in Acknowledgments (2). Some journals now
include the World Association of Medical Editors www                    request and publish information about the contributions of
.WAME.org and the Council of Science Editors www                        each person named as having participated in a submitted
.councilofscienceeditors.                                               study, at least for original research. Editors are strongly
                                                                        encouraged to develop and implement a contributorship
I. B. Potential Users of the Uniform Requirements                       policy, as well as a policy on identifying who is responsible
     The ICMJE created the Uniform Requirements pri-                    for the integrity of the work as a whole.
marily to help authors and editors in their mutual task of                   While contributorship and guarantorship policies ob-
creating and distributing accurate, clear, easily accessible            viously remove much of the ambiguity surrounding contri-
reports of biomedical studies. The initial sections address             butions, they leave unresolved the question of the quantity
the ethical principles related to the process of evaluating,            and quality of contribution that qualify for authorship.
improving, and publishing manuscripts in biomedical jour-               The ICJME has recommended the following criteria for
nals and the relationships among editors and authors, peer              authorship; these criteria are still appropriate for journals
reviewers, and the media. The latter sections address the               that distinguish authors from other contributors.
more technical aspects of preparing and submitting manu-                     Y Authorship credit should be based on 1) substantial
scripts. The ICMJE believes that the entire document is                 contributions to conception and design, acquisition of
relevant to the concerns of both authors and editors.                   data, or analysis and interpretation of data; 2) drafting the
     The Uniform Requirements can provide many other                    article or revising it critically for important intellectual
stakeholders—peer reviewers, publishers, the media, pa-                 content; and 3) final approval of the version to be pub-
tients and their families, and general readers—with useful              lished. Authors should meet conditions 1, 2, and 3.
insights into the biomedical authoring and editing process.                  Y When a large, multicenter group has conducted the
2                                                                                                                           www.icmje.org
                                                           Uniform Requirements for Manuscripts Submitted to Biomedical Journals


work, the group should identify the individuals who accept         tigators” or “participating investigators,” and their function
direct responsibility for the manuscript (3). These individ-       or contribution should be described—for example, “served
uals should fully meet the criteria for authorship/contribu-       as scientific advisors,” “critically reviewed the study pro-
torship defined above and editors will ask these individuals        posal,” “collected data,” or “provided and cared for study
to complete journal-specific author and conflict-of-interest         patients.” Because readers may infer their endorsement of
disclosure forms. When submitting a manuscript authored            the data and conclusions, these persons must give written
by a group, the corresponding author should clearly indi-          permission to be acknowledged.
cate the preferred citation and identify all individual au-        II. B. Editorship
thors as well as the group name. Journals generally list           II. B. 1. The Role of the Editor
other members of the group in the Acknowledgments. The                  The editor of a journal is the person responsible for its
NLM indexes the group name and the names of individu-              entire content. Owners and editors of medical journals
als the group has identified as being directly responsible for      have a common endeavor—publication of a reliable, read-
the manuscript; it also lists the names of collaborators if        able journal produced with due respect for the stated aims
they are listed in Acknowledgments.                                of the journal and for costs. Owners and editors, however,
     Y Acquisition of funding, collection of data, or gen-         have different functions. Owners have the right to appoint
eral supervision of the research group alone does not con-         and dismiss editors and to make important business deci-
stitute authorship.                                                sions in which editors should be involved to the fullest
     Y All persons designated as authors should qualify for        extent possible. Editors must have full authority for deter-
authorship, and all those who qualify should be listed.            mining the editorial content of the journal. The concept of
     Y Each author should have participated sufficiently in         editorial freedom should be resolutely defended by editors
the work to take public responsibility for appropriate por-        even to the extent of their placing their positions at stake.
tions of the content.                                              To secure this freedom in practice, the editor should have
     Some journals now also request that one or more au-           direct access to the highest level of ownership, not to a
thors, referred to as “guarantors,” be identified as the per-       delegated manager.
sons who take responsibility for the integrity of the work as           Editors of medical journals should have a contract that
a whole, from inception to published article, and publish          clearly states his or her rights and duties, the general terms
that information.                                                  of the appointment, and the mechanisms for resolving con-
     Increasingly, authorship of multicenter trials is attrib-     flict.
uted to a group. All members of the group who are named                 An independent editorial advisory board may be useful
as authors should fully meet the above criteria for author-        in helping the editor establish and maintain editorial pol-
ship/contributorship.                                              icy.
     The group should jointly make decisions about con-
tributors/authors before submitting the manuscript for
                                                                   II. B. 2. Editorial Freedom
publication. The corresponding author/guarantor should
be prepared to explain the presence and order of these                  The ICMJE adopts the World Association of Medical
individuals. It is not the role of editors to make authorship/     Editors’ definition of editorial freedom. According to this
contributorship decisions or to arbitrate conflicts related to      definition, editorial freedom, or independence, is the con-
authorship.                                                        cept that editors-in-chief have full authority over the edi-
                                                                   torial content of their journal and the timing of publica-
                                                                   tion of that content. Journal owners should not interfere in
II. A. 2. Contributors Listed in Acknowledgments                   the evaluation, selection, or editing of individual articles
     All contributors who do not meet the criteria for au-         either directly or by creating an environment that strongly
thorship should be listed in an acknowledgments section.           influences decisions. Editors should base decisions on the
Examples of those who might be acknowledged include a              validity of the work and its importance to the journal’s
person who provided purely technical help, writing assis-          readers not on the commercial success of the journal. Ed-
tance, or a department chairperson who provided only gen-          itors should be free to express critical but responsible views
eral support. Editors should ask corresponding authors to          about all aspects of medicine without fear of retribution,
declare whether they had assistance with study design, data        even if these views conflict with the commercial goals of
collection, data analysis, or manuscript preparation. If such      the publisher. Editors and editors’ organizations have the
assistance was available, the authors should disclose the          obligation to support the concept of editorial freedom and
identity of the individuals who provided this assistance and       to draw major transgressions of such freedom to the atten-
the entity that supported it in the published article. Finan-      tion of the international medical, academic, and lay com-
cial and material support should also be acknowledged.             munities.
     Groups of persons who have contributed materially to          II. C. Peer Review
the paper but whose contributions do not justify author-                Unbiased, independent, critical assessment is an in-
ship may be listed under such headings as “clinical inves-         trinsic part of all scholarly work, including the scientific
www.icmje.org                                                                                                                      3
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


process. Peer review is the critical assessment of manu-                in the manuscript on a conflict-of-interest notification page
scripts submitted to journals by experts who are not part of            that follows the title page, providing additional detail, if
the editorial staff. Peer review can therefore be viewed as an          necessary, in a cover letter that accompanies the manu-
important extension of the scientific process. Although its              script. (See Section IV. A. 3. Conflict-of-Interest Notification
actual value has been little studied and is widely debated              Page)
(4), peer review helps editors decide which manuscripts are                  Authors should identify Individuals who provide writ-
suitable for their journals and helps authors and editors to            ing or other assistance and disclose the funding source for
improve the quality of reporting. A peer-reviewed journal               this assistance.
submits most of its published research articles for outside                  Investigators must disclose potential conflicts to study
review. The number and kinds of manuscripts sent for                    participants and should state in the manuscript whether
review, the number of reviewers, the reviewing procedures,              they have done so.
and the use made of the reviewers’ opinions may vary. In                     Editors also need to decide whether to publish infor-
the interests of transparency, each journal should publicly             mation disclosed by authors about potential conflicts. If
disclose its policies in its Instructions to Authors.                   doubt exists, it is best to err on the side of publication.
II. D. Conflicts of Interest
     Public trust in the peer-review process and the credi-             II. D. 2. Potential Conflicts of Interest Related to Project
bility of published articles depend in part on how well                 Support
conflict of interest is handled during writing, peer review,                  Increasingly, individual studies receive funding from
and editorial decision making. Conflict of interest exists               commercial firms, private foundations, and government.
when an author (or the author’s institution), reviewer, or              The conditions of this funding have the potential to bias
editor has financial or personal relationships that inappro-             and otherwise discredit the research.
priately influence (bias) his or her actions (such relation-                  Scientists have an ethical obligation to submit credit-
ships are also known as dual commitments, competing in-                 able research results for publication. Moreover, as the per-
terests, or competing loyalties). These relationships vary              sons directly responsible for their work, researchers should
from negligible to great potential for influencing judg-                 not enter into agreements that interfere with their access to
ment. Not all relationships represent true conflict of inter-            the data and their ability to analyze them independently,
est. On the other hand, the potential for conflict of interest           and to prepare and publish manuscripts. Authors should
can exist regardless of whether an individual believes that             describe the role of the study sponsor, if any, in study
the relationship affects his or her scientific judgment. Fi-             design; collection, analysis, and interpretation of data; writ-
nancial relationships (such as employment, consultancies,               ing the report; and the decision to submit the report for
stock ownership, honoraria, and paid expert testimony) are              publication. If the supporting source had no such involve-
the most easily identifiable conflicts of interest and the                ment, the authors should so state. Biases potentially intro-
most likely to undermine the credibility of the journal, the            duced when sponsors are directly involved in research are
authors, and of science itself. However, conflicts can occur             analogous to methodological biases. Some journals, there-
for other reasons, such as personal relationships, academic             fore, choose to include information in the Methods section
competition, and intellectual passion.                                  about the sponsor’s involvement.
     All participants in the peer-review and publication                     Editors may request that authors of a study funded by
process must disclose all relationships that could be viewed            an agency with a proprietary or financial interest in the
as potential conflicts of interest. Disclosure of such rela-             outcome sign a statement, such as “I had full access to all
tionships is also important in connection with editorials               of the data in this study and I take complete responsibility
and review articles, because it can be more difficult to de-             for the integrity of the data and the accuracy of the data
tect bias in these types of publications than in reports of             analysis.” Editors should be encouraged to review copies of
original research. Editors may use information disclosed in             the protocol and/or contracts associated with project-spe-
conflict-of-interest and financial-interest statements as a               cific studies before accepting such studies for publication.
basis for editorial decisions. Editors should publish this              Editors may choose not to consider an article if a sponsor
information if they believe it is important in judging the              has asserted control over the authors’ right to publish.
manuscript.
                                                                        II. D. 3. Potential Conflicts of Interest Related to Commitments
II. D. 1. Potential Conflicts of Interest Related to Individual          of Editors, Journal Staff, or Reviewers
Authors’ Commitments                                                        Editors should avoid selecting external peer reviewers
    When authors submit a manuscript, whether an article                with obvious potential conflicts of interest–for example,
or a letter, they are responsible for disclosing all financial           those who work in the same department or institution as
and personal relationships that might bias their work. To               any of the authors. Authors often provide editors with the
prevent ambiguity, authors must state explicitly whether                names of persons they feel should not be asked to review a
potential conflicts do or do not exist. Authors should do so             manuscript because of potential, usually professional, con-
4                                                                                                                               www.icmje.org
                                                            Uniform Requirements for Manuscripts Submitted to Biomedical Journals


flicts of interest. When possible, authors should be asked to        formed consent has been obtained, it should be indicated
explain or justify their concerns; that information is impor-       in the published article.
tant to editors in deciding whether to honor such requests.
     Reviewers must disclose to editors any conflicts of in-
                                                                    II. E. 2. Authors and Reviewers
terest that could bias their opinions of the manuscript, and
                                                                          Manuscripts must be reviewed with due respect for
they should recuse themselves from reviewing specific
                                                                    authors’ confidentiality. In submitting their manuscripts
manuscripts if the potential for bias exists. As in the case of
                                                                    for review, authors entrust editors with the results of their
authors, silence on the part of reviewers concerning poten-
                                                                    scientific work and creative effort, on which their reputa-
tial conflicts may mean either that conflicts exist and the
                                                                    tion and career may depend. Authors’ rights may be vio-
reviewer has failed to disclose them or conflicts do not
                                                                    lated by disclosure of the confidential details during review
exist. Reviewers must therefore also be asked to state ex-
                                                                    of their manuscript. Reviewers also have rights to confiden-
plicitly whether conflicts do or do not exist. Reviewers
                                                                    tiality, which must be respected by the editor. Confidenti-
must not use knowledge of the work, before its publica-
                                                                    ality may have to be breached if dishonesty or fraud is
tion, to further their own interests.
                                                                    alleged but otherwise must be honored.
     Editors who make final decisions about manuscripts
                                                                          Editors must not disclose information about manu-
must have no personal, professional, or financial involve-
                                                                    scripts (including their receipt, content, status in the re-
ment in any of the issues they might judge. Other mem-
                                                                    viewing process, criticism by reviewers, or ultimate fate) to
bers of the editorial staff, if they participate in editorial
                                                                    anyone other than the authors and reviewers. This includes
decisions, must provide editors with a current description
                                                                    requests to use the materials for legal proceedings.
of their financial interests (as they might relate to editorial
                                                                          Editors must make clear to their reviewers that manu-
judgments) and recuse themselves from any decisions in
                                                                    scripts sent for review are privileged communications and
which a conflict of interest exists. Editorial staff must not
                                                                    are the private property of the authors. Therefore, review-
use information gained through working with manuscripts
                                                                    ers and members of the editorial staff must respect the
for private gain. Editors should publish regular disclosure
                                                                    authors’ rights by not publicly discussing the authors’ work
statements about potential conflicts of interests related to
                                                                    or appropriating their ideas before the manuscript is pub-
the commitments of journal staff.
                                                                    lished. Reviewers must not be allowed to make copies of
II. E. Privacy and Confidentiality                                  the manuscript for their files and must be prohibited from
II. E. 1. Patients and Study Participants                           sharing it with others, except with the editor’s permission.
     Patients have a right to privacy that should not be            Reviewers should return or destroy copies of manuscripts
violated without informed consent. Identifying informa-             after submitting reviews. Editors should not keep copies of
tion, including names, initials, or hospital numbers, should        rejected manuscripts.
not be published in written descriptions, photographs, or                 Reviewer comments should not be published or oth-
pedigrees unless the information is essential for scientific         erwise publicized without permission of the reviewer, au-
purposes and the patient (or parent or guardian) gives writ-        thor, and editor.
ten informed consent for publication. Informed consent                    Opinions differ on whether reviewers should remain
for this purpose requires that an identifiable patient be            anonymous. Authors should consult the Information for
shown the manuscript to be published. Authors should                Authors of the journal to which they have chosen to sub-
disclose to these patients whether any potential identifiable        mit a manuscript to determine whether reviews are anon-
material might be available via the Internet as well as in          ymous. When comments are not signed, the reviewers’
print after publication. Patient consent should be written          identity must not be revealed to the author or anyone else
and archived either with the journal, the authors, or both,         without the reviewers’ permission.
as dictated by local regulations or laws. Applicable laws                 Some journals publish reviewers’ comments with the
vary from locale to locale, and journals should establish           manuscript. No such procedure should be adopted without
their own policies with legal guidance.                             the consent of the authors and reviewers. However, review-
     Nonessential identifying details should be omitted. In-        ers’ comments should be sent to other persons reviewing
formed consent should be obtained if there is any doubt             the same manuscript, which helps reviewers learn from the
that anonymity can be maintained. For example, masking              review process. Reviewers also may be notified of the edi-
the eye region in photographs of patients is inadequate             tor’s decision to accept or reject a manuscript.
protection of anonymity. If identifying characteristics are         II. F. Protection of Human Subjects and Animals in
altered to protect anonymity, such as in genetic pedigrees,         Research
authors should provide assurance, and editors should so                 When reporting experiments on human subjects, au-
note, that such alterations do not distort scientific mean-          thors should indicate whether the procedures followed
ing.                                                                were in accordance with the ethical standards of the re-
     The requirement for informed consent should be in-             sponsible committee on human experimentation (institu-
cluded in the journal’s Instructions for Authors. When in-          tional and national) and with the Helsinki Declaration of
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      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


1975, as revised in 2000 (5). If doubt exists whether the               listed in the Table of Contents page, and include in its
research was conducted in accordance with the Helsinki                  heading the title of the original article. It should not simply
Declaration, the authors must explain the rationale for                 be a letter to the editor. Ideally, the first author of the
their approach and demonstrate that the institutional re-               retraction should be the same as that of the article, al-
view body explicitly approved the doubtful aspects of the               though under certain circumstances the editor may accept
study. When reporting experiments on animals, authors                   retractions by other responsible persons. The text of the
should indicate whether the institutional and national                  retraction should explain why the article is being retracted
guide for the care and use of laboratory animals was fol-               and include a complete citation reference to that article.
lowed.                                                                       The validity of previous work by the author of a fraud-
                                                                        ulent paper cannot be assumed. Editors may ask the au-
                                                                        thor’s institution to assure them of the validity of earlier
III. PUBLISHING AND EDITORIAL ISSUES RELATED             TO
                                                                        work published in their journals or to retract it. If this is
PUBLICATION IN BIOMEDICAL JOURNALS                                      not done, editors may choose to publish an announcement
III. A. Obligation to Publish Negative Studies                          expressing concern that the validity of previously published
     Editors should consider seriously for publication any              work is uncertain.
carefully done study of an important question, relevant to                   Editors who have questions related to editorial or sci-
their readers, whether the results for the primary or any               entific misconduct may find it useful to consult the excel-
additional outcome are statistically significant. Failure to             lent flow charts that the Committee on Publication Ethics
submit or publish findings because of lack of statistical                (COPE) has developed (www.publicationethics.org.uk ).
significance is an important cause of publication bias.                  COPE, which was formed in 1997, is a forum in which
III. B. Corrections, Retractions, and “Expressions of                   editors of peer-reviewed journals can discuss issues related
Concern”                                                                to the integrity of the scientific record; it supports and
     Editors must assume initially that authors are report-             encourages editors to report, catalogue, and instigate inves-
ing work based on honest observations. Nevertheless, two                tigations into ethical problems in the publication process.
types of difficulty may arise.                                           COPE’s major objective is to provide a sounding board for
     First, errors may be noted in published articles that              editors struggling with how best to deal with possible
require the publication of a correction or erratum on part              breaches in research and publication ethics.
of the work. The corrections should appear on a numbered
                                                                        III. C. Copyright
page, be listed in the Table of Contents, include the com-
                                                                             Many biomedical journals ask authors to transfer
plete original citation, and link to the original article and
                                                                        copyright to the journal. However, an increasing number
vice versa if online. It is conceivable that an error could be
                                                                        of “open-access” journals do not require transfer of copy-
so serious as to vitiate the entire body of the work, but this
                                                                        right. Editors should make their position on copyright
is unlikely and should be addressed by editors and authors
                                                                        transfer clear to authors and to others who might be inter-
on an individual basis. Such an error should not be con-
                                                                        ested in using editorial content from their journals. The
fused with inadequacies exposed by the emergence of new
                                                                        copyright status of articles in a given journal can vary:
scientific information in the normal course of research.
                                                                        Some content cannot be copyrighted (for example, articles
The latter requires no corrections or withdrawals.
                                                                        written by employees of the U.S. and some other govern-
     The second type of difficulty is scientific fraud. If sub-
                                                                        ments in the course of their work); editors may agree to
stantial doubts arise about the honesty or integrity of work,
                                                                        waive copyright on others; and still others may be pro-
either submitted or published, it is the editor’s responsibil-
                                                                        tected under serial rights (that is, use in publications other
ity to ensure that the question is appropriately pursued,
                                                                        than journals, including electronic publications, is permit-
usually by the authors’ sponsoring institution. Ordinarily it
                                                                        ted).
is not the responsibility of the editor to conduct a full
investigation or to make a determination; that responsibil-             III. D. Overlapping Publications
ity lies with the institution where the work was done or                III. D. 1. Duplicate Submission
with the funding agency. The editor should be promptly                       Most biomedical journals will not consider manu-
informed of the final decision, and if a fraudulent paper                scripts that are simultaneously being considered by other
has been published, the journal must print a retraction. If             journals. Among the principal considerations that have led
this method of investigation does not result in a satisfac-             to this policy are: 1) the potential for disagreement when
tory conclusion, the editor may choose to conduct his or                two (or more) journals claim the right to publish a manu-
her own investigation. As an alternative to retraction, the             script that has been submitted simultaneously to more than
editor may choose to publish an expression of concern                   one; and 2) the possibility that two or more journals will
about aspects of the conduct or integrity of the work.                  unknowingly and unnecessarily undertake the work of peer
     The retraction or expression of concern, so labeled,               review, edit the same manuscript, and publish the same
should appear on a numbered page in a prominent section                 article.
of the print journal as well as in the online version, be                    However, editors of different journals may decide to
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                                                            Uniform Requirements for Manuscripts Submitted to Biomedical Journals


simultaneously or jointly publish an article if they believe        occurs without such notification, authors should expect ed-
that doing so would be in the best interest of public health.       itorial action to be taken. At the least, prompt rejection of
                                                                    the submitted manuscript should be expected. If the editor
                                                                    was not aware of the violations and the article has already
III. D. 2. Redundant Publication                                    been published, then a notice of redundant or duplicate
     Redundant (or duplicate) publication is publication of         publication will probably be published with or without the
a paper that overlaps substantially with one already pub-           author’s explanation or approval.
lished in print or electronic media.                                     Preliminary reporting to public media, governmental
     Readers of primary source periodicals, whether print           agencies, or manufacturers of scientific information de-
or electronic, deserve to be able to trust that what they are       scribed in a paper or a letter to the editor that has been
reading is original unless there is a clear statement that the      accepted but not yet published violates the policies of
author and editor are intentionally republishing an article.        many journals. Such reporting may be warranted when the
The bases of this position are international copyright laws,        paper or letter describes major therapeutic advances or
ethical conduct, and cost-effective use of resources. Dupli-        public health hazards, such as serious adverse effects of
cate publication of original research is particularly prob-         drugs, vaccines, other biological products, or medicinal de-
lematic, since it can result in inadvertent double counting         vices, or reportable diseases. This reporting should not
or inappropriate weighting of the results of a single study,        jeopardize publication, but should be discussed with and
which distorts the available evidence.                              agreed upon by the editor in advance.
     Most journals do not wish to receive papers on work
that has already been reported in large part in a published
article or is contained in another paper that has been sub-         III. D. 3. Acceptable Secondary Publication
mitted or accepted for publication elsewhere, in print or in              Certain types of articles, such as guidelines produced
electronic media. This policy does not preclude the journal         by governmental agencies and professional organizations,
considering a paper that has been rejected by another jour-         may need to reach the widest possible audience. In such
nal, or a complete report that follows publication of a pre-        instances, editors sometimes deliberately publish material
liminary report, such as an abstract or poster displayed at a       that is also being published in other journals, with the
professional meeting. It also does not prevent journals             agreement of the authors and the editors of those journals.
from considering a paper that has been presented at a sci-          Secondary publication for various other reasons, in the
entific meeting but was not published in full or that is             same or another language, especially in other countries, is
being considered for publication in a proceedings or simi-          justifiable and can be beneficial provided that the following
lar format. Brief press reports of scheduled meetings are           conditions are met.
not usually regarded as breaches of this rule, but they may               1. The authors have received approval from the editors
be if additional data or copies of tables and figures amplify        of both journals; the editor concerned with secondary pub-
such reports. The ICMJE does not consider results posted            lication must have a photocopy, reprint, or manuscript of
in clinical trial registries as previous publication if the re-     the primary version.
sults are presented in the same, ICMJE-accepted registry in               2. The priority of the primary publication is respected
which initial registration of trial methods occurred and if         by a publication interval of at least 1 week (unless specifi-
the results are posted in the form of a brief structured            cally negotiated otherwise by both editors).
abstract or table. The ICMJE also believes that the results               3. The paper for secondary publication is intended for
registry should either cite full publications of the results        a different group of readers; an abbreviated version could
when available or include a statement that indicates that           be sufficient.
the results have not yet been published in a peer-reviewed                4. The secondary version faithfully reflects the data
journal.                                                            and interpretations of the primary version.
     When submitting a paper, the author must always                      5. The footnote on the title page of the secondary
make a complete statement to the editor about all submis-           version informs readers, peers, and documenting agencies
sions and previous reports (including meeting presenta-             that the paper has been published in whole or in part and
tions and posting of results in registries) that might be           states the primary reference. A suitable footnote might
regarded as redundant or duplicate publication. The au-             read: “This article is based on a study first reported in the
thor must alert the editor if the manuscript includes sub-          [title of journal, with full reference].”
jects about which the authors have published a previous                   Permission for such secondary publication should be
report or have submitted a related report to another pub-           free of charge.
lication. Any such report must be referred to and refer-                  6. The title of the secondary publication should indi-
enced in the new paper. Copies of such material should be           cate that it is a secondary publication (complete republica-
included with the submitted manuscript to help the editor           tion, abridged republication, complete translation, or
decide how to handle the matter.                                    abridged translation) of a primary publication. Of note,
     If redundant or duplicate publication is attempted or          the NLM does not consider translations to be “republica-
www.icmje.org                                                                                                                       7
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


tions” and does not cite or index translations when the                 III. D. 5. Competing Manuscripts Based on the Same Database
original article was published in a journal that is indexed in               Editors sometimes receive manuscripts from separate
MEDLINE.                                                                research groups that have analyzed the same data set (for
     7. Editors of journals that simultaneously publish in              example, from a public database). The manuscripts may
multiple languages should understand that NLM indexes                   differ in their analytic methods, conclusions, or both. Each
the primary language version. When the full text of an                  manuscript should be considered separately. If interpreta-
article appears in more than one language in a journal issue            tion of the data is very similar, it is reasonable but not
(such as Canadian journals with the article in both English             mandatory for editors to give preference to the manuscript
and French), both languages are indicated in the MED-                   that was received first. However, editorial consideration of
LINE citation (for example, Mercer K. The relentless chal-              multiple submissions may be justified under these circum-
lenge in health care. Healthc Manage Forum. 2008 Sum-                   stances, and there may even be a good reason to publish
mer;21(2):4-5. English, French. No abstract available.                  more than one manuscript because different analytical ap-
PMID:18795553.)                                                         proaches may be complementary and equally valid.

                                                                        III. E. Correspondence
                                                                             The corresponding author/guarantor has primary re-
III. D. 4. Competing Manuscripts Based on the Same Study
                                                                        sponsibility for correspondence with the journal, but the
     Publication of manuscripts to air the disputes of co-              ICMJE recommends that editors send a copy of any cor-
investigators may waste journal space and confuse readers.              respondence to all listed authors.
On the other hand, if editors knowingly publish a manu-                      Biomedical journals should provide the readership
script written by only some of a collaborating team, they               with a mechanism for submitting comments, questions, or
could be denying the rest of the team their legitimate co-              criticisms about published articles, as well as brief reports
authorship rights and journal readers access to legitimate              and commentary unrelated to previously published articles.
differences of opinion about the interpretation of a study.             This probably but not necessarily takes the form of a cor-
     Two kinds of competing submissions are considered:                 respondence section or column. The authors of articles
submissions by coworkers who disagree on the analysis and               discussed in correspondence should be given an opportu-
interpretation of their study, and submissions by coworkers             nity to respond, preferably in the same issue in which the
who disagree on what the facts are and which data should                original correspondence appears. Authors of correspon-
be reported.                                                            dence should be asked to declare any competing or con-
     Setting aside the unresolved question of ownership of              flicting interests.
the data, the following general observations may help edi-                   Published correspondence may be edited for length,
tors and others address such problems.                                  grammatical correctness, and journal style. Alternatively,
     III. D. 4. a. Differences in Analysis or Interpretation If         editors may choose to publish unedited correspondence,
the dispute centers on the analysis or interpretation of data,          for example in rapid-response sections on the Internet. The
the authors should submit a manuscript that clearly pre-                journal should declare its editorial practices in this regard.
sents both versions. The difference of opinion should be                Authors should approve editorial changes that alter the
explained in a cover letter. The normal process of peer and             substance or tone of a letter or response. In all instances,
editorial review may help the authors to resolve their dis-             editors must make an effort to screen out discourteous,
agreement regarding analysis or interpretation.                         inaccurate, or libelous statements and should not allow ad
     If the dispute cannot be resolved and the study merits             hominem arguments intended to discredit opinions or
publication, both versions should be published. Options                 findings.
include publishing two papers on the same study, or a                        Although editors have the prerogative to reject corre-
single paper with two analyses or interpretations. In such              spondence that is irrelevant, uninteresting, or lacking co-
cases, it would be appropriate for the editor to publish a              gency, they have a responsibility to allow a range of opin-
statement outlining the disagreement and the journal’s in-              ions to be expressed. The correspondence column should
volvement in attempts to resolve it.                                    not be used merely to promote the journal’s or the editors’
     III. D. 4. b. Differences in Reported Methods or Results If        point of view.
the dispute centers on differing opinions of what was ac-                    In the interests of fairness and to keep correspondence
tually done or observed during the study, the journal editor            within manageable proportions, journals may want to set
should refuse publication until the disagreement is re-                 time limits for responding to published material and for
solved. Peer review cannot be expected to resolve such                  debate on a given topic. Journals should also decide
problems. If there are allegations of dishonesty or fraud,              whether they would notify authors when correspondence
editors should inform the appropriate authorities; authors              bearing on their published work is going to appear in stan-
should be notified of an editor’s intention to report a sus-             dard or rapid-response sections. Journals should also set
picion of research misconduct.                                          policy with regard to the archiving of unedited correspon-
8                                                                                                                           www.icmje.org
                                                           Uniform Requirements for Manuscripts Submitted to Biomedical Journals


dence that appears online. These policies should be pub-           III. G. Electronic Publishing
lished both in print and electronic versions of the journal.            Most biomedical journals are now published in elec-
                                                                   tronic as well as print versions, and some are published
III. F. Supplements, Theme Issues, and Special Series              only in electronic form. Because electronic publishing
      Supplements are collections of papers that deal with         (which includes the Internet) is the same as publishing in
related issues or topics, are published as a separate issue of     print, in the interests of clarity and consistency the recom-
the journal or as part of a regular issue, and are usually         mendations of this document should be applied to elec-
funded by sources other than the journal’s publisher. Sup-         tronically published medical and health information.
plements can serve useful purposes: education, exchange of              The nature of electronic publication requires some
research information, ease of access to focused content, and       special considerations, both within and beyond this docu-
improved cooperation between academic and corporate en-            ment. At a minimum, Web sites should indicate the fol-
tities. Because funding sources can bias the content of sup-       lowing: names, appropriate credentials, affiliations, and rel-
plements through the choice of topics and viewpoints,              evant conflicts of interest of editors, authors, and
journals should consider adopting the following principles.        contributors; documentation and attribution of references
These same principles apply to theme issues or special se-         and sources for all content; information about copyright;
ries that have external funding and/or guest editors.              disclosure of site ownership; and disclosure of sponsorship,
      1. The journal editor must take full responsibility for      advertising, and commercial funding.
                                                                        Linking from one health or medical Internet site to
the policies, practices, and content of supplements, includ-
                                                                   another may be perceived as an implicit recommendation
ing complete control of the decision to publish all portions
                                                                   of the quality of the second site. Journals thus should ex-
of the supplement. Editing by the funding organization
                                                                   ercise caution in linking to other sites; when users are link-
should not be permitted.                                           ing to another site, it may be helpful to provide an explicit
      2. The journal editor must retain the authority to send      statement that they are leaving the journal’s site. Links to
supplement manuscripts for external peer review and to             other sites posted as a result of financial considerations
reject manuscripts submitted for the supplement. These             should be clearly indicated as such. All dates of content
conditions should be made known to authors and external            posting and updating should be indicated. In electronic
supplement editors before beginning editorial work on the          layout as in print, advertising and promotional messages
supplement.                                                        should not be juxtaposed with editorial content, and com-
      3. The journal editor must approve the appointment           mercial content should be clearly identified as such.
of any external editor of the supplement and take respon-               Electronic publication is in flux. Editors should de-
sibility for the work of the external editor.                      velop, make available to authors, and implement policies
      4. The sources of funding for the research, publica-         on issues unique to electronic publishing. These issues in-
tion, and products of the funding source that are consid-          clude archiving, error correction, version control, choice of
ered in the supplement should be clearly stated and prom-          the electronic or print version of the journal as the journal
inently located in the supplement, preferably on each page.        of record, and publication of ancillary material.
Whenever possible, supplements should be funded by                      Under no circumstances should a journal remove an
more than one sponsor.                                             article from its Web site or archive. If a correction or re-
      5. Advertising in supplements should follow the same         traction becomes necessary, the explanation must be la-
policies as those of the rest of the journal.                      beled appropriately and communicated as soon as possible
      6. Journal editors must enable readers to distinguish        on a citable page in a subsequent issue of the journal.
readily between ordinary editorial pages and supplement                 Preservation of electronic articles in a permanent ar-
pages.                                                             chive is essential for the historical record. Access to the
      7. Journal editors and supplement editors must not           archive should be immediate and should be controlled by a
accept personal favors or remuneration from sponsors of            third party, such as a library, instead of the publisher. Dep-
                                                                   osition in multiple archives is encouraged.
supplements.
      8. Secondary publication in supplements (republica-          III. H. Advertising
tion of papers published elsewhere) should be clearly iden-             Most medical journals carry advertising, which gener-
tified by the citation of the original paper. Supplements           ates income for their publishers, but advertising must not
should avoid redundant or duplicate publication. Supple-           be allowed to influence editorial decisions. Journals should
ments should not republish research results, but republica-        have formal, explicit, written policies for advertising in
tion of guidelines or other material in the public interest        both print and electronic versions; Web site advertising
might be appropriate.                                              policy should parallel that for the print version to the ex-
      9. The principles of authorship and disclosure of po-        tent possible. Editors must have full and final authority for
tential conflicts of interest discussed elsewhere in this doc-      approving advertisements and enforcing advertising policy.
ument should be applied to supplements.                                 When possible, editors should make use of the judg-
www.icmje.org                                                                                                                      9
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


ments of independent bodies for reviewing advertising.                       Editors may find the following recommendations use-
Readers should be able to distinguish readily between ad-               ful as they seek to establish policies on these issues.
vertising and editorial material. The juxtaposition of edi-                  Y Editors can foster the orderly transmission of med-
torial and advertising material on the same products or                 ical information from researchers, through peer-reviewed
subjects should be avoided. Interleafing advertising pages               journals, to the public. This can be accomplished by an
within articles interrupts the flow of editorial content and             agreement with authors that they will not publicize their
should be discouraged. Advertising should not be sold on                work while their manuscript is under consideration or
the condition that it will appear in the same issue as a                awaiting publication and an agreement with the media that
particular article.                                                     they will not release stories before publication of the orig-
     Journals should not be dominated by advertising, but               inal research in the journal, in return for which the journal
editors should be careful about publishing advertisements               will cooperate with them in preparing accurate stories.
from only one or two advertisers, as readers may perceive                    Y Editors need to keep in mind that an embargo sys-
that these advertisers have influenced the editor.                       tem works on the honor system; no formal enforcement or
     Journals should not carry advertisements for products              policing mechanism exists. The decision of a significant
that have proved to be seriously harmful to health—for                  number of media outlets or biomedical journals not to
example, tobacco. Editors should ensure that existing reg-              respect the embargo system would lead to its rapid disso-
ulatory or industry standards for advertisements specific to             lution.
their country are enforced, or develop their own standards.                  Y Very little medical research has such clear and ur-
The interests of organizations or agencies should not con-              gently important clinical implications for the public’s
trol classified and other nondisplay advertising, except                 health that the news must be released before full publica-
where required by law. Finally, editors should consider all             tion in a journal. However, if such exceptional circum-
criticisms of advertisements for publication.                           stances occur, the appropriate authorities responsible for
                                                                        public health should decide whether to disseminate infor-
III. I. Medical Journals and the General Media                          mation to physicians and the media in advance and should
     The public’s interest in news of medical research has              be responsible for this decision. If the author and the ap-
led the popular media to compete vigorously for informa-                propriate authorities wish to have a manuscript considered
tion about research. Researchers and institutions some-                 by a particular journal, the editor should be consulted be-
times encourage reporting research in the nonmedical me-                fore any public release. If editors acknowledge the need for
dia before full publication in a scientific journal by holding           immediate release, they should waive their policies limiting
a press conference or giving interviews.                                prepublication publicity.
     The public is entitled to important medical informa-                    Y Policies designed to limit prepublication publicity
tion within a reasonable amount of time, and editors have               should not apply to accounts in the media of presentations
a responsibility to facilitate the process. Biomedical jour-            at scientific meetings or to the abstracts from these meet-
nals are published primarily for their readers, but the gen-            ings (see Redundant Publication). Researchers who present
eral public has a legitimate interest in their content: An              their work at a scientific meeting should feel free to discuss
appropriate balance between these considerations should                 their presentations with reporters, but they should be dis-
guide the journal’s interaction with the media. Doctors in              couraged from offering more detail about their study than
practice need to have reports available in full detail before           was presented in the talk.
they can advise their patients about the reports’ conclu-                    Y When an article is soon to be published, editors
sions. Moreover, media reports of scientific research before             should help the media prepare accurate reports by provid-
the work has been peer reviewed and fully vetted may lead               ing news releases, answering questions, supplying advance
to dissemination of inaccurate or premature conclusions.                copies of the journal, or referring reporters to the appro-
     An embargo system has been established in some                     priate experts. This assistance should be contingent on the
countries to prevent publication of stories in the general              media’s cooperation in timing the release of a story to
media before publication of the original research in the                coincide with publication of the article.
journal. The embargo creates a “level playing field,” which                   Y Editors, authors, and the media should apply the
most reporters appreciate since it minimizes the pressure               above-stated principles to material released early in elec-
on them to publish stories which they have not had time to              tronic versions of journals.
prepare carefully. Consistency in the timing of public re-
lease of biomedical information is also important in mini-              III. J. Obligation to Register Clinical Trials
mizing economic chaos, since some articles contain infor-                   The ICMJE believes that it is important to foster a
mation that has great potential to influence financial                    comprehensive, publicly available database of clinical trials.
markets. On the other hand, the embargo system has been                 The ICMJE defines a clinical trial as any research project
challenged as being self-serving of journals’ interests and an          that prospectively assigns human subjects to intervention
impediment to rapid dissemination of scientific informa-                 or concurrent comparison or control groups to study the
tion.                                                                   cause-and-effect relationship between a medical interven-
10                                                                                                                          www.icmje.org
                                                              Uniform Requirements for Manuscripts Submitted to Biomedical Journals


tion and a health outcome. Medical interventions include              mation in a journal’s Instructions to Authors is designed to
drugs, surgical procedures, devices, behavioral treatments,           accomplish that goal in ways that meet each journal’s par-
process-of-care changes, and the like.                                ticular editorial needs. The following information provides
      The ICMJE member journals will require, as a condi-             guidance in preparing manuscripts for any journal.
tion of consideration for publication in their journals, reg-
istration in a public trials registry. The details of this policy     IV. A. 1. a. General Principles
are contained in a series of editorials (see Editorials, under             The text of observational and experimental articles is
Frequently Asked Questions). The ICMJE encourages ed-                 usually (but not necessarily) divided into the following sec-
itors of other biomedical journals to adopt similar policy.           tions: Introduction, Methods, Results, and Discussion.
      The ICMJE does not advocate one particular registry,            This so-called “IMRAD” structure is not an arbitrary pub-
but its member journals will require authors to register              lication format but rather a direct reflection of the process
their trial in a registry that meets several criteria. The reg-       of scientific discovery. Long articles may need subheadings
istry must be accessible to the public at no charge. It must          within some sections (especially Results and Discussion) to
be open to all prospective registrants and managed by a               clarify their content. Other types of articles, such as case
not-for-profit organization. There must be a mechanism to              reports, reviews, and editorials, probably need to be for-
ensure the validity of the registration data, and the registry        matted differently.
should be electronically searchable. An acceptable registry                Electronic formats have created opportunities for add-
must include at minimum the data elements listed in Table             ing details or whole sections, layering information, cross-
1. Trial registration with missing fields or fields that con-           linking or extracting portions of articles, and the like only
tain uninformative terminology is inadequate.                         in the electronic version. Authors need to work closely with
      It is important to note that the ICMJE requires regis-          editors in developing or using such new publication for-
tration of trial methodology but does not require registra-           mats and should submit supplementary electronic material
tion of trial results; it recognizes the potential problems           for peer review.
that could arise from the posting of research results that                 Double spacing all portions of the manuscript— in-
have not been subjected to an independent peer-review                 cluding the title page, abstract, text, acknowledgments, ref-
process. However, the ICMJE understands that the U.S.                 erences, individual tables, and legends—and generous mar-
Food and Drug Administration Amendments Act of 2007                   gins make it possible for editors and reviewers to edit the
(FDAAA) does require researchers to register results. The             text line by line and add comments and queries directly on
ICMJE will not consider to be previous publication results            the paper copy. If manuscripts are submitted electronically,
posted in the same primary clinical trial registry as the             the files should be double-spaced to facilitate printing for
initial registration if the results are posted in the tabular         reviewing and editing.
form dictated by the FDAAA. Researchers should be aware                    Authors should number all of the pages of the manu-
that editors of journals that follow the ICMJE recommen-              script consecutively, beginning with the title page, to facil-
dations may consider more detailed description of trial re-           itate the editorial process.
sults and results published in registries other than the pri-
mary registry (in the case of FDAAA, ClinicalTrials.gov) to
                                                                      IV. A. 1. b. Reporting Guidelines for Specific Study Designs
be prior publication. The ICMJE anticipates that the cli-
mate for results registration will change dramatically over                Research reports frequently omit important informa-
coming years and the ICMJE may need to amend these                    tion. Reporting guidelines (Table 2) have been developed
recommendations as additional agencies institute other                for a number of study designs that some journals may ask
mandates related to results registration.                             authors to follow. Authors should consult the Information
      The ICMJE recommends that journals publish the                  for Authors of the journal they have chosen.
trial registration number at the end of the abstract. The                  The general requirements listed in the next section
ICMJE also recommends that, whenever a registration                   relate to reporting essential elements for all study designs.
number is available, authors list the registration number             Authors are encouraged also to consult reporting guidelines
the first time they use a trial acronym to refer to either the         relevant to their specific research design. For reports of
trial they are reporting or to other trials that they mention         randomized, controlled trials, authors should refer to the
in the manuscript.                                                    CONSORT statement. This guideline provides a set of
                                                                      recommendations comprising a list of items to report and a
                                                                      patient flow diagram.
IV. MANUSCRIPT PREPARATION           AND   SUBMISSION
IV. A. Preparing a Manuscript for Submission to a                     IV. A .2. Title Page
Biomedical Journal                                                         The title page should have the following information:
     Editors and reviewers spend many hours reading                        1. Article title. Concise titles are easier to read than
manuscripts, and therefore appreciate receiving manu-                 long, convoluted ones. Titles that are too short may, how-
scripts that are easy to read and edit. Much of the infor-            ever, lack important information, such as study design
www.icmje.org                                                                                                                         11
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


(which is particularly important in identifying randomized,             background for the study and should state the study’s pur-
controlled trials). Authors should include all information              pose, basic procedures (selection of study subjects or labora-
in the title that will make electronic retrieval of the article         tory animals, observational and analytical methods), main
both sensitive and specific.                                             findings (giving specific effect sizes and their statistical signif-
     2. Authors’ names and institutional affiliations. Some              icance, if possible), and principal conclusions. It should em-
journals publish each author’s highest academic degree(s),              phasize new and important aspects of the study or observa-
while others do not.                                                    tions. Articles on clinical trials should contain abstracts that
     3. The name of the department(s) and institution(s) to             include the items that the CONSORT group has identified as
which the work should be attributed.                                    essential (www.consort-statement.org/? 1190 ).
     4. Disclaimers, if any.                                                  Because abstracts are the only substantive portion of
     5. Contact information for corresponding authors.                  the article indexed in many electronic databases, and the
The name, mailing address, telephone and fax numbers,                   only portion many readers read, authors need to be careful
and e-mail address of the author responsible for correspon-             that they accurately reflect the content of the article. Un-
dence about the manuscript (the “corresponding author;”                 fortunately, the information contained in many abstracts
this author may or may not be the “guarantor” for the                   differs from that in the text (6). The format required for
integrity of the study). The corresponding author should                structured abstracts differs from journal to journal, and
indicate clearly whether his or her e-mail address can be               some journals use more than one format; authors need to
published.                                                              prepare their abstracts in the format specified by the jour-
     6. The name and address of the author to whom re-                  nal they have chosen.
quests for reprints should be addressed or a statement that                   The ICMJE recommends that journals publish the
reprints are not available from the authors.                            trial registration number at the end of the abstract. The IC-
     7. Source(s) of support in the form of grants, equip-              MJE also recommends that, whenever a registration number
ment, drugs, or all of these.                                           is available, authors list that number the first time they use a
     8. A running head. Some journals request a short run-              trial acronym to refer to either the trial they are reporting or to
ning head or footline, usually no more than 40 characters               other trials that they mention in the manuscript.
(including letters and spaces) at the foot of the title page.
Running heads are published in most journals, but are also
sometimes used within the editorial office for filing and                 IV. A. 5. Introduction
locating manuscripts.                                                        Provide a context or background for the study (that is,
     9. Word counts. A word count for the text only (ex-                the nature of the problem and its significance). State the
cluding abstract, acknowledgments, figure legends, and ref-              specific purpose or research objective of, or hypothesis
erences) allows editors and reviewers to assess whether the             tested by, the study or observation; the research objective is
information contained in the paper warrants the amount of               often more sharply focused when stated as a question. Both
space devoted to it, and whether the submitted manuscript               the main and secondary objectives should be clear, and any
fits within the journal’s word limits. A separate word count             prespecified subgroup analyses should be described. Pro-
for the Abstract is useful for the same reason.                         vide only directly pertinent references, and do not include
     10. The number of figures and tables. It is difficult for            data or conclusions from the work being reported.
editorial staff and reviewers to determine whether the fig-
ures and tables that should have accompanied a manuscript
were actually included unless the numbers of figures and                 IV. A. 6. Methods
tables are noted on the title page.                                          The Methods section should include only information
                                                                        that was available at the time the plan or protocol for the
                                                                        study was being written; all information obtained during
IV. A. 3. Conflict-of-Interest Notification Page
                                                                        the study belongs in the Results section.
     To prevent the information on potential conflicts of
                                                                             IV. A. 6. a. Selection and Description of Participants
interest from being overlooked or misplaced, it needs to be
                                                                        Describe your selection of the observational or experimen-
part of the manuscript. However, it should also be in-
                                                                        tal participants (patients or laboratory animals, including
cluded on a separate page or pages immediately following
                                                                        controls) clearly, including eligibility and exclusion criteria
the title page. Individual journals may differ in where they
                                                                        and a description of the source population. Because the
include this information, and some journals do not send
                                                                        relevance of such variables as age and sex to the object of
information on conflicts of interest to reviewers. (See Sec-
                                                                        research is not always clear, authors should explain their
tion II. D. Conflicts of Interest.)
                                                                        use when they are included in a study report–for example,
                                                                        authors should explain why only participants of certain
IV. A. 4. Abstract                                                      ages were included or why women were excluded. The
    The abstract (requirements for length and format vary)              guiding principle should be clarity about how and why a
should follow the title page. It should provide the context or          study was done in a particular way. When authors use such
12                                                                                                                              www.icmje.org
                                                           Uniform Requirements for Manuscripts Submitted to Biomedical Journals


variables as race or ethnicity, they should define how they         in detail data or other information given in the Introduc-
measured these variables and justify their relevance.              tion or the Results section. For experimental studies, it is
     IV. A. 6. b. Technical Information Identify the meth-         useful to begin the discussion by summarizing briefly the
ods, apparatus (give the manufacturer’s name and address           main findings, then explore possible mechanisms or expla-
in parentheses), and procedures in sufficient detail to allow       nations for these findings, compare and contrast the results
others to reproduce the results. Give references to estab-         with other relevant studies, state the limitations of the
lished methods, including statistical methods (see below);         study, and explore the implications of the findings for fu-
provide references and brief descriptions for methods that         ture research and for clinical practice.
have been published but are not well-known; describe new                Link the conclusions with the goals of the study but
or substantially modified methods, give the reasons for us-         avoid unqualified statements and conclusions not ade-
ing them, and evaluate their limitations. Identify precisely       quately supported by the data. In particular, avoid making
all drugs and chemicals used, including generic name(s),           statements on economic benefits and costs unless the
dose(s), and route(s) of administration.                           manuscript includes the appropriate economic data and
     Authors submitting review manuscripts should include          analyses. Avoid claiming priority or alluding to work that
a section describing the methods used for locating, select-        has not been completed. State new hypotheses when war-
ing, extracting, and synthesizing data. These methods              ranted, but label them clearly as such.
should also be summarized in the abstract.
     IV. A. 6. c. Statistics Describe statistical methods with
enough detail to enable a knowledgeable reader with access         IV. A. 9. References
to the original data to verify the reported results. When               IV. A. 9. a. General Considerations Related to References
possible, quantify findings and present them with appro-            Although references to review articles can be an efficient
priate indicators of measurement error or uncertainty (such        way to guide readers to a body of literature, review articles
as confidence intervals). Avoid relying solely on statistical       do not always reflect original work accurately. Readers
hypothesis testing, such as P values, which fail to convey         should therefore be provided with direct references to orig-
important information about effect size. References for the        inal research sources whenever possible. On the other
design of the study and statistical methods should be to           hand, extensive lists of references to original work on a
standard works when possible (with pages stated). Define            topic can use excessive space on the printed page. Small
statistical terms, abbreviations, and most symbols. Specify        numbers of references to key original papers often serve as
the computer software used.                                        well as more exhaustive lists, particularly since references
     IV. A. 7. Results Present your results in logical se-         can now be added to the electronic version of published
quence in the text, tables, and illustrations, giving the main     papers, and since electronic literature searching allows
or most important findings first. Do not repeat all the data         readers to retrieve published literature efficiently.
in the tables or illustrations in the text; emphasize or sum-           Avoid using abstracts as references. References to pa-
marize only the most important observations. Extra or sup-         pers accepted but not yet published should be designated
plementary materials and technical detail can be placed in         as “in press” or “forthcoming”; authors should obtain writ-
an appendix where they will be accessible but will not             ten permission to cite such papers as well as verification
interrupt the flow of the text, or they can be published            that they have been accepted for publication. Information
solely in the electronic version of the journal.                   from manuscripts submitted but not accepted should be
     When data are summarized in the Results section, give         cited in the text as “unpublished observations” with written
numeric results not only as derivatives (for example, per-         permission from the source.
centages) but also as the absolute numbers from which the               Avoid citing a “personal communication” unless it pro-
derivatives were calculated, and specify the statistical meth-     vides essential information not available from a public source,
ods used to analyze them. Restrict tables and figures to            in which case the name of the person and date of communi-
those needed to explain the argument of the paper and to           cation should be cited in parentheses in the text. For scientific
assess supporting data. Use graphs as an alternative to ta-        articles, obtain written permission and confirmation of accu-
bles with many entries; do not duplicate data in graphs and        racy from the source of a personal communication.
tables. Avoid nontechnical uses of technical terms in statis-           Some but not all journals check the accuracy of all
tics, such as “random” (which implies a randomizing de-            reference citations; thus, citation errors sometimes appear
vice), “normal,” “significant,” “correlations,” and “sample.”       in the published version of articles. To minimize such er-
     Where scientifically appropriate, analyses of the data         rors, verify references against the original documents. Au-
by such variables as age and sex should be included.               thors are responsible for checking that none of the refer-
                                                                   ences cite retracted articles except in the context of
                                                                   referring to the retraction. For articles published in jour-
IV. A. 8. Discussion                                               nals indexed in MEDLINE, the ICMJE considers PubMed
    Emphasize the new and important aspects of the study           the authoritative source for information about retractions.
and the conclusions that follow from them. Do not repeat           Authors can identify retracted articles in MEDLINE by
www.icmje.org                                                                                                                      13
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


using the following search term, where pt in square brack-              IV. A. 11. Illustrations (Figures)
ets stands for publication type: Retracted publication [pt]                  Figures should be either professionally drawn and pho-
in PubMed.                                                              tographed, or submitted as photographic-quality digital
     IV. A. 9. b. Reference Style and Format The Uniform                prints. In addition to requiring a version of the figures
Requirements style for references is based largely on an                suitable for printing, some journals now ask authors for
American National Standards Institute style adapted by the              electronic files of figures in a format (for example, JPEG or
NLM for its databases. Authors should consult NLM’s Cit-                GIF) that will produce high-quality images in the Web
ing Medicine for information on its recommended formats                 version of the journal; authors should review the images of
for a variety of reference types.                                       such files on a computer screen before submitting them to
     References should be numbered consecutively in the                 be sure they meet their own quality standards.
order in which they are first mentioned in the text. Identify                 For x-ray films, scans, and other diagnostic images, as
references in text, tables, and legends by Arabic numerals              well as pictures of pathology specimens or photomicro-
                                                                        graphs, send sharp, glossy, black-and-white or color pho-
in parentheses. References cited only in tables or figure
                                                                        tographic prints, usually 127 x 173 mm (5 x 7 inches).
legends should be numbered in accordance with the se-
                                                                        Although some journals redraw figures, many do not. Let-
quence established by the first identification in the text of
                                                                        ters, numbers, and symbols on figures should therefore be
the particular table or figure. The titles of journals should
                                                                        clear and consistent throughout, and large enough to re-
be abbreviated according to the style used in the list of               main legible when the figure is reduced for publication.
Journals Indexed for MEDLINE, posted by the NLM on                      Figures should be made as self-explanatory as possible,
the Library’s Web site. Journals vary on whether they ask               since many will be used directly in slide presentations. Ti-
authors to cite electronic references within parentheses in             tles and detailed explanations belong in the legends–not on
the text or in numbered references following the text. Au-              the illustrations themselves.
thors should consult with the journal to which they plan to                  Photomicrographs should have internal scale markers.
submit their work.                                                      Symbols, arrows, or letters used in photomicrographs
                                                                        should contrast with the background.
                                                                             Photographs of potentially identifiable people must be
IV. A. 10. Tables                                                       accompanied by written permission to use the photograph.
     Tables capture information concisely and display it                     Figures should be numbered consecutively according
efficiently; they also provide information at any desired                to the order in which they have been cited in the text. If a
level of detail and precision. Including data in tables rather          figure has been published previously, acknowledge the
than text frequently makes it possible to reduce the length             original source and submit written permission from the
of the text.                                                            copyright holder to reproduce the figure. Permission is re-
     Type or print each table with double spacing on a                  quired irrespective of authorship or publisher except for
separate sheet of paper. Number tables consecutively in the             documents in the public domain.
order of their first citation in the text and supply a brief                  For illustrations in color, ascertain whether the journal
title for each. Do not use internal horizontal or vertical              requires color negatives, positive transparencies, or color
                                                                        prints. Accompanying drawings marked to indicate the re-
lines. Give each column a short or an abbreviated heading.
                                                                        gion to be reproduced might be useful to the editor. Some
Authors should place explanatory matter in footnotes, not
                                                                        journals publish illustrations in color only if the author
in the heading. Explain all nonstandard abbreviations in
                                                                        pays the additional cost.
footnotes, and use the following symbols, in sequence:
                                                                             Authors should consult the journal about require-
     *, †, ‡, §, ||, ¶, **, ††, ‡‡                                      ments for figures submitted in electronic formats.
     Identify statistical measures of variations, such as stan-
dard deviation and standard error of the mean.                          IV. A. 12. Legends for Illustrations (Figures)
     Be sure that each table is cited in the text.                           Type or print out legends for illustrations using dou-
     If you use data from another published or unpublished              ble spacing, starting on a separate page, with Arabic nu-
source, obtain permission and acknowledge that source fully.            merals corresponding to the illustrations. When symbols,
     Additional tables containing backup data too extensive             arrows, numbers, or letters are used to identify parts of the
to publish in print may be appropriate for publication in               illustrations, identify and explain each one clearly in the
the electronic version of the journal, deposited with an                legend. Explain the internal scale and identify the method
archival service, or made available to readers directly by the          of staining in photomicrographs.
authors. An appropriate statement should be added to the
text to inform readers that this additional information is              IV. A. 13. Units of Measurement
available and where it is located. Submit such tables for                     Measurements of length, height, weight, and volume
consideration with the paper so that they will be available             should be reported in metric units (meter, kilogram, or
to the peer reviewers.                                                  liter) or their decimal multiples.
14                                                                                                                          www.icmje.org
                                                          Uniform Requirements for Manuscripts Submitted to Biomedical Journals


     Temperatures should be in degrees Celsius. Blood                   Y The name, address, and telephone number of the
pressures should be in millimeters of mercury, unless other       corresponding author, who is responsible for communicat-
units are specifically required by the journal.                    ing with the other authors about revisions and final ap-
     Journals vary in the units they use for reporting hema-      proval of the proofs, if that information is not included in
tologic, clinical chemistry, and other measurements. Au-          the manuscript itself.
thors must consult the Information for Authors of the par-              The letter should give any additional information that
ticular journal and should report laboratory information in       may be helpful to the editor, such as the type or format of
both local and International System of Units (SI). Editors        article in the particular journal that the manuscript repre-
may request that authors add alternative or non-SI units,         sents. If the manuscript has been submitted previously to
since SI units are not universally used. Drug concentra-          another journal, it is helpful to include the previous edi-
tions may be reported in either SI or mass units, but the         tor’s and reviewers’ comments with the submitted manu-
alternative should be provided in parentheses where appro-        script, along with the authors’ responses to those com-
priate.                                                           ments. Editors encourage authors to submit these previous
                                                                  communications. Doing so may expedite the review pro-
                                                                  cess.
IV. A. 14. Abbreviations and Symbols
                                                                        Many journals now provide a presubmission checklist
     Use only standard abbreviations; use of nonstandard
                                                                  to help the author ensure that all the components of the
abbreviations can be confusing to readers. Avoid abbrevia-
                                                                  submission have been included. Some journals now also
tions in the title of the manuscript. The spelled-out abbre-
                                                                  require that authors complete checklists for reports of cer-
viation followed by the abbreviation in parenthesis should
                                                                  tain study types (for example, the CONSORT checklist for
be used on first mention unless the abbreviation is a stan-
                                                                  reports of randomized, controlled trials). Authors should
dard unit of measurement.
                                                                  look to see if the journal uses such checklists, and send
IV. B. Sending the Manuscript to the Journal                      them with the manuscript if they are requested.
     An increasing number of journals now accept elec-                  Letters of permission to reproduce previously pub-
tronic submission of manuscripts, whether on disk, as an          lished material, use previously published illustrations, re-
e-mail attachment, or by downloading directly onto the            port information about identifiable persons, or to acknowl-
journal’s Web site. Electronic submission saves time and          edge people for their contributions must accompany the
money and allows the manuscript to be handled in elec-            manuscript.
tronic form throughout the editorial process (for example,
when it is sent out for review). For specific instructions on
electronic submission, authors should consult the journal’s
                                                                  V. REFERENCES
                                                                  A. References Cited in This Document
Instructions for Authors.
     If a paper version of the manuscript is submitted, send          1. Davidoff F, for the CSE Task Force on Authorship.
the required number of copies of the manuscript and fig-           Who’s the author? Problems with biomedical authorship,
ures; they are all needed for peer review and editing, and        and some possible solutions. Science Editor. 2000;
the editorial office staff cannot be expected to make the          23:111-9.
required copies.                                                      2. Yank V, Rennie D. Disclosure of researcher contri-
     Manuscripts must be accompanied by a cover letter,           butions: a study of original research articles in The Lancet.
which should include the following information.                   Ann Intern Med. 1999;130:661-70.
     Y A full statement to the editor about all submissions           3. Flanagin A, Fontanarosa PB, DeAngelis CD. Au-
and previous reports that might be regarded as redundant          thorship for research groups. JAMA. 2002;288:3166-8.
publication of the same or very similar work. Any such                4. Godlee F, Jefferson T. Peer Review in Health Sci-
work should be referred to specifically and referenced in          ences. London: BMJ Books; 1999.
the new paper. Copies of such material should be included             5. World Medical Association Declaration of Helsinki.
with the submitted paper to help the editor address the           Ethical principles for medical research involving human
situation.                                                        subjects. JAMA. 2000;284:3043-5.
     Y A statement of financial or other relationships that            6. Pitkin RM, Branagan MA, Burmeister LF. Accuracy
might lead to a conflict of interest, if that information is       of data in abstracts of published research articles. JAMA.
not included in the manuscript itself or in an authors’           1999;281:1110-1.
form.                                                             B. Other Sources of Information Related to Biomedical
     Y A statement that the manuscript has been read and          Journals
approved by all the authors, that the requirements for au-             World Association of Medical Editors (WAME)
thorship as stated earlier in this document have been met,             Council of Science Editors (CSE)
and that each author believes that the manuscript repre-               European Association of Science Editors (EASE)
sents honest work if that information is not provided in               Cochrane Collaboration
another form (see below).                                              Committee on Publication Ethics (COPE)
www.icmje.org                                                                                                                     15
      Uniform Requirements for Manuscripts Submitted to Biomedical Journals


VI. ABOUT THE INTERNATIONAL COMMITTEE                OF                 reprinted or translated versions of the document. Thus,
MEDICAL JOURNAL EDITORS                                                 any translations should prominently include the following
     The ICMJE is a group of general medical journal ed-                statement: “This is a (reprint /(insert language name) lan-
itors whose participants meet annually and fund their work              guage translation) of the ICMJE Uniform Requirements for
on the Uniform Requirements for Manuscripts. The IC-                    Manuscripts Submitted to Biomedical Journals. (insert
MJE invites comments on this document and suggestions                   name of organization) prepared this translation with sup-
for agenda items.                                                       port from (insert name of funding source, if any). The IC-
                                                                        MJE has neither endorsed nor approved the contents of
                                                                        this reprint/translation. The ICMJE periodically updates
VII. AUTHORS OF THE UNIFORM REQUIREMENTS FOR                            the Uniform Requirements, so this reprint/translation pre-
MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS                            pared on (insert date) may not accurately represent the cur-
     The ICMJE participating journals and organizations                 rent official version at www.ICMJE.org. The official ver-
and their representatives who approved the revised Uni-                 sion of the Uniform Requirements for Manuscripts
form Requirements for Manuscripts in September 2008                     Submitted to Biomedical Journals is located at www.IC-
include Annals of Internal Medicine, British Medical Jour-              MJE.org.”
nal, Canadian Medical Association Journal, Croatian Medi-                    We do not require individuals or organizations that
cal Journal, Journal of the American Medical Association,               reprint or translate the Uniform Requirements for Manu-
Nederlands Tijdschrift voor Geneeskunde (The Dutch Medi-                scripts Submitted to Biomedical Journals to obtain formal,
cal Journal), New England Journal of Medicine, New Zea-                 written permission from the ICMJE. However, the ICMJE
land Medical Journal, The Lancet, The Medical Journal of                requests that such individuals or organizations provide the
Australia, Tidsskrift for Den Norske Lægeforening (The Jour-            ICMJE secretariat with the citation for that reprint or
nal of the Norwegian Medical Association), Ugeskrift for Lae-           translation so that the ICMJE can keep a record of such
ger (Journal of the Danish Medical Association), the U.S.               versions of the document.
NLM, and the World Association of Medical Editors.
                                                                        IX. INQUIRIES
VIII. USE, DISTRIBUTION,      AND    TRANSLATION      OF THE                 Before sending an inquiry, please consult Frequently
UNIFORM REQUIREMENTS                                                    Asked Questions at www.icmje.org, as this section of the
    Users may print, copy, and distribute this document                 Web site provides answers to the most commonly asked
without charge for not-for-profit, educational purpose.                  questions.
The ICMJE does not stock paper copies (reprints) of this                     Inquiries about the Uniform Requirements should be
document.                                                               sent to Christine Laine, MD, MPH at the ICMJE Secre-
    The ICMJE policy is for interested organizations to                 tariat office, American College of Physicians, 190 N. Inde-
link to the official English language document at www                    pendence Mall West, Philadelphia, PA 19106-1572, USA.
.ICMJE.org. The ICMJE does not endorse posting of the                   e-mail claine@acponline.org. Please do not direct inquiries
document on Web sites other than that of the ICMJE.                     about individual studies, individual journal styles, or indi-
    The ICMJE welcomes organizations to reprint or                      vidual journal policies to the ICMJE secretariat office. The
translate this document into languages other than English               ICMJE does not archive individual journal contact infor-
for nonprofit purposes. However, the ICMJE does not                      mation. Manuscripts intended for submission to a journal
have the resources to translate, back-translate, or approve             must be sent directly to the journal, not to the ICMJE.




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