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«Publication Policies and Procedures for the Journals of the American Diabetes Association Last updated 30 October 2015 The American Diabetes Care ...»

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Publication Policies and Procedures for the Journals of the

American Diabetes Association

Last updated 30 October 2015

The American Diabetes Care Association (ADA) follows the recommendations of the International

Committee of Medical Journal Editors (ICMJE), the World Association of Medical Editors (WAME), and

the Committee on Publication Ethics (COPE) for guidance on policies and procedures related to

publication ethics. The policies listed below have been adopted from those three advisory bodies and, where necessary, modified and tailored to meet the specific content, audiences, and aims of the journals of the American Diabetes Association (Diabetes®, Diabetes Care, Clinical Diabetes®, and Diabetes Spectrum®). The Association or its Panel on Ethical Scientific Programs (ESP) will consider on a case-by-case basis policies that are not addressed below.

Contents Study Design

Originality and Prior Publication

Authorship and Contributions


Conflict of Interest

Data Access and Responsibility

Clinical Trials, Systematic Reviews, and Meta-Analyses

Common Forms of Scientific Misconduct

Responses to Possible Scientific or Publishing Misconduct

Reporting Concerns Related to Scientific Misconduct

Peer Review

Editorial Decisions

Prepublication of Accepted Articles

Copyright, Reuse, and Public Access

Errata, Retractions, and Addenda

Media Embargos




Study Design In accordance with the recommendations of WAME, research submitted to ADA Journals should be well justified, well planned, and appropriately designed so that it can properly address the research objective of the study described in the manuscript. Statistical issues, including power calculations, should be described to avoid futile studies that produce subject risk without enrollment sufficient to address the research objective. Outcomes should be specified at the start of the study. Research should be conducted to high standards of quality control and data analysis. Data and records, including the original versions of manuscripts, figures, and other files and supporting materials, must be retained by authors for a period of 7 years and must be able to be produced for review, if requested by the editors.

Fabrication, falsification, concealment, deceptive reporting, or misrepresentation of data constitutes scientific misconduct.

In addition, and in line with WAME’s recommendations, ADA requires documented review and approval from a formally constituted review board (institutional review board or ethics committee) for all studies involving people, medical records, and human tissues. For those investigators who do not have access to formal ethics review committees, the principles outlined in the World Medical Association’s Declaration of Helsinki should be followed. If the study is judged exempt from review, a statement from the committee is required; authors should provide this statement at the time of manuscript submission.

Informed consent by participants must be attained. If not possible, an institutional review board must decide if this is ethically acceptable; review board approval must be attested to and described in the comments to the editor upon manuscript submission and in the RESEARCH DESIGN AND METHODS section of the manuscript itself.

Studies and experiments using animals require full compliance with local, national, ethical, and regulatory principles, and local licensing arrangements.

ADA journals require the reporting of sex for cells, tissues, and experimental animals and humans (i.e., male and female) where appropriate and suitable for the experimental design of the research effort;

studies should report whether sex was considered a factor in the statistical analysis of the data.

Originality and Prior Publication ADA journals publish only original work that has not been previously published. All authors of manuscripts submitted to ADA journals must attest that neither the manuscript nor any part of it, regardless of the language in which it was originally written or published, has been published or is under consideration for publication elsewhere. Previous publication of an


during the proceedings of meetings (in print or electronically) is not considered prior publication and therefore does not preclude subsequent submission for publication. At the time of submission and in the ACKNOWLEDGMENTS section, authors should disclose whether the study described in the manuscript has been previously presented at a meeting or published in abstract form in the proceedings of a meeting.

Any reference to or use of previously published material protected by copyright must be explicitly acknowledged in the manuscript. Posting of submitted material on a website may be considered prior publication and should be noted in the comments to the editor upon submission. Redundant publication—when multiple papers, without full cross-reference in the text, share the same data or results—is not permissible. At the time of submission, authors should disclose details of related papers they have authored, even if authored in a different language; similar papers in press; and any closely related papers previously published or currently under review at another journal.

Authorship and Contributions ADA journals subscribe to the requirements stated in ICMJE’s Recommendations for the Conduct,

Reporting, Editing, and Publication of Scholarly Work in Medical Journals that authorship implies:

 Substantial contributions to conception and design of the work; or the acquisition, analysis, or interpretation of data for the work; and  Drafting the work or revising it critically for important intellectual content; and  Final approval of the version to be published; and  Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

All authors should meet these above conditions, and ADA requires for all listed authors to list their contributions to the study and/or manuscript in a section titled “Author Contributions” on the title page of the manuscript. If the article is accepted for publication, this information will be included after the main text in the published version of the manuscript.

In addition, ADA has adopted the following ICMJE recommendations related to authorship and


 When a large, multicenter group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship defined above, and these individuals must complete the mandatory Manuscript Submission Form, which requires authors to outline contributions and relevant conflict-of-interest.

 When submitting a manuscript authored by a group, the corresponding author should clearly indicate the preferred citation and identify all individual authors as well as the group name;

other collaborators should be listed in the ACKNOWLEDGMENTS. The National Library of Medicine (NLM) indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript; it also lists the names of collaborators if they are listed in ACKNOWLEDGMENTS.

 Acquisition of funding, collection of data, collection of patient and/or samples from other species, or general supervision of the research group alone does not constitute authorship.

 All persons designated as authors should qualify for authorship, and all those who qualify should be listed.

 Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

 All authors must take responsibility in writing for the accuracy of the manuscript, and one or more authors, such as the corresponding or lead author, must be the guarantor and take responsibility for the work as a whole.

Acknowledgments The role of or contribution by any individual or entity included in the ACKNOWLEDGMENTS section of the manuscript must be clearly defined. Editors or ADA staff may contact authors to clarify the roles or contributions of any person or entity acknowledged in the manuscript, particularly if that person or entity provided “editorial assistance” or help with “preparing” or “drafting” the manuscript. Authors should avoid vague or broad descriptions of contributions of acknowledged individuals or entities;

descriptions of contributions should be clear, specific, and precise.

ADA requires that authors list the employer or institutional affiliation of any individual mentioned in the ACKNOWLEDGMENTS section. If this information is not included at the time of submission, editorial office staff will request the corresponding author to submit a new version of the manuscript that includes the required information.

Conflict of Interest ADA journals require all participants in the peer-review and publication process to disclose all relationships that could be viewed as potential conflicts of interest. Editors may use information disclosed in conflict-of-interest and financial-interest statements as a basis for editorial decisions.

All authors should refer to the ADA Policy Statement on Duality of Interest and submit relevant conflictof-interest statements with ADA’s mandatory Manuscript Submission Form. In lieu of completing the conflict-of-interest section on the Manuscript Submission Form, authors may submit ICMJE's Uniform Disclosure Form for Potential Conflicts of Interest.

In addition, for all manuscript submissions, regardless of article type, all authors should include conflictof-interest statements in both the comments to the editors at the time of submission and within the ACKNOWLEDGMENTS section of the manuscript itself. If authors have no relevant conflicts of interest to disclose, this should also be indicated in both sections.

Examples of potential conflict of interest include:

 Employment, membership on the board of directors, or any fiduciary relationship with a thirdparty entity engaged in the development, manufacture, or sale of pharmaceutical or medical devices, supplies, or information  Ownership of stock or receipt of honoraria, travel or meeting expenses, or consulting or review fees from a third-party entity, as described above  Receipt of financial support or grants for research from a third-party entity, as described above  Holding patents or receiving royalties related to the development of pharmaceutical or medical devices, supplies, or information  Receipt of writing assistance, medicines, equipment, or administrative support from a thirdparty entity, as described above  Membership on a scientific advisory panel or other standing scientific/medical committee  Receipt of payment or honoraria for author contributions or author designation  Any other relationships that readers could perceive to have influenced, or that give the appearance of potentially influencing, the content of the submitted work.

Investigators must disclose potential conflicts-of-interest to study participants and should state in the manuscript whether they have done so.

If the study was sponsored by a third party, authors should describe the role of the study sponsor in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state. At the time of submission, ADA requires that the submitting author of a study funded by an agency with a proprietary or financial interest in indicate that she/he had full access to all of the data in the study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis. This author, unless otherwise specified, will be listed in the published version of the article as the “guarantor” of the study.

Please note that the editors may request a statistical analysis of all data by an independent biostatistician, and will decline to consider an article if a sponsor has asserted control over the authors’ right to publish.

Peer reviewers for ADA publications are required to disclose to editors any conflicts of interest that could bias their opinions of the manuscript. Likewise, the Editor and Associate Editors are required to recuse themselves of any final decision on manuscripts for which they may have personal or professional biases. In such cases, a different member of the Editorial Team, or an “Ad Hoc Editor” (e.g., a previous Editor-in-Chief of the journal), will be appointed to adjudicate the review of the manuscript and render a decision on the manuscript.

Authors are encouraged to provide editors with the names of persons they feel should not be asked to review a manuscript because of potential conflicts of interest. Authors should explain their concerns in their comments to the editor at the time of submission; the editors will take this information into account when determining who to invite to review the manuscript.

Data Access and Responsibility The American Diabetes Association has adopted the data access and responsibility policies developed by

the Journal of the American Medical Association:

For all reports (regardless of funding source) containing original data, at least one named author (e.g., the principal investigator) who is independent of any commercial funder or sponsor must indicate that he or she is the “guarantor” of the study (i.e., he or she had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis). A statement identifying the guarantor should be included in the Acknowledgments section at the end of the manuscript. Modified statements or generic statements indicating that all authors had such access are not acceptable.

The statement should appear as follows:

C.K. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Modified statements or generic statements indicating that all authors had such access are not acceptable.

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