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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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For industry-sponsored studies, the editors reserve the right to request an analysis of the data (based on the entire raw dataset and evaluation of the study protocol, and prespecified plan for data analysis) by an independent statistician at an academic institution, rather than by statisticians employed by the sponsor or by a commercial contract research organization. In such cases, the independent biostatistician must be a faculty member at a medical school or academic medical center, or an employee of a government research institute, that has oversight over the person conducting the analysis and that is independent of the commercial sponsor. Details of this independent statistical analysis, the name and institutional affiliation of the independent statistician, and whether compensation or funding was received for conducting the analyses should be reported in the Acknowledgments section of the manuscript. The results of this independent statistical analysis should be the results reported in the manuscript.

Clinical Trials, Systematic Reviews, and Meta-Analyses ADA journals adhere to ICMJE’s clinical trials registration policy, which is summarized in section III-K of ICMJE’s Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. ICMJE defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” All clinical trials submitted to ADA journals must be registered with an ICMJEapproved clinical trial registry (such as clinicaltrials.gov) prior to patient enrollment. If your manuscript is considered a clinical trial but has not been registered, it will not be considered for publication in the journal. ADA accepts registration of clinical trials in any of the primary registries that participate in the World Health Organization International Clinical Trial Registry Platform. Authors must include the unique clinical trial number, the name of the registry, and the URL to the registration on the manuscript’s title page.

Authors of reports on randomized controlled trials (RCTs) are required to complete the checklist outlined in the Consolidated Standards of Reporting Trials (CONSORT) Statement. The instructions and checklist are designed to ensure that information pertinent to the trial is included in the study report.

ADA requires that the CONSORT checklist is submitted with RCT manuscripts; CONSORT information may be posted with accepted manuscripts as online-only supplementary materials at the request of the editors or the authors.

Authors of reports on systematic reviews and meta-analyses are required to complete the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram that have been developed to help authors improve the reporting of systematic reviews and meta-analyses. ADA requires that the completed checklist and diagram are submitted with systematic reviews and meta-analyses; PRISMA information may be posted with accepted manuscripts as online-only supplementary materials at the request of the editors or the authors.

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.

Common Forms of Scientific Misconduct The most common forms of scientific misconduct, with minor modification from Analysis of Institutional Policies for Responding to Allegations of Scientific Misconduct by the U.S. Department of Health and Human Services’ Office of Research Integrity, are listed below.

 Falsification of data: ranging from fabrication to deceptive selective reporting of findings and omission of conflicting data, willful suppression and/or distortion of data, and inappropriate or fraudulent digital image manipulation. For more information about ADA’s image manipulation policies, please see the section below.

 Plagiarism: The appropriation of the language, ideas, or thoughts of another and representation of them as one’s own original work, or the duplication or re-use of one’s previously published work without proper acknowledgment. For more information about plagiarism and how ADA detects for plagiarism, see the section below.

 Improprieties of authorship: Improper assignment of credit, such as excluding others, misrepresentation of the same material as original in more than one publication, inclusion of individuals as authors who have not made a definite contribution to the work published; or submission of multi-authored publications without the concurrence of all authors.

 Violation of generally accepted research practices: Serious deviation from accepted practices in proposing or carrying out research, improper manipulation of experiments to obtain biased results, deceptive statistical or analytical manipulations, or improper reporting of results.

 Material failure to comply with federal requirements affecting research: Including but not limited to serious or substantial, repeated, willful violations involving the use of funds, care of animals, human subjects, investigational drugs, recombinant products, new devices, or radioactive, biologic, or chemical materials.





 Inappropriate behavior in relation to misconduct: Including inappropriate accusation of misconduct; failure to report known or suspected misconduct; withholding or destruction of information relevant to a claim of misconduct and retaliation against person involved in the allegation or investigation.

 Deliberate misrepresentation of qualifications, experience, or research accomplishments to advance the research program, to obtain external funding, or for other professional advancement.

 Misappropriation of funds or resources. For example, misuse of funds for personal gain.

ADA’s plagiarism and image manipulation policies are further described below.

Plagiarism. Manuscripts submitted to ADA Journals will be uploaded to CrossCheck/iThenticate, plagiarism detection software, to scan the document for plagiarized text. Plagiarism is scientific misconduct and will be addressed as such.

According to WAME, “Plagiarism is the use of others' published and unpublished ideas or words (or other intellectual property) without attribution or permission, and presenting them as new and original rather than derived from an existing source. The intent and effect of plagiarism is to mislead the reader as to the contributions of the plagiarizer. This applies whether the ideas or words are taken from abstracts, research grant applications, Institutional Review Board applications, or unpublished or published manuscripts in any publication format (print or electronic).” Self-plagiarism refers to the practice of an author using portions of their previous writings on the same topic in another of his/her publications, without specifically and formally citing the previously published work. ADA will allow authors to reuse only their own succinctly written literature reviews and brief descriptions of methodologies or patient characteristics from previously published work. Authors who do so should disclose this information in their comments to the editors at the time of submission, and any reused methodology descriptions from previously published work should be properly cited. As mentioned before, all manuscripts submitted to ADA Journals are scanned for possible plagiarized and reused text using the CrossCheck/iThenticate software. To avoid possible concerns or peer-review delays, authors should make a concerted effort to reword or rewrite text borrowed from the methodology descriptions of their own work. “Avoiding plagiarism, self-plagiarism, and other questionable writing practices,” a resource developed by Miguel Roig, PhD, with funding from ORI, provides useful information on best practices related to ethical writing.

Cases of suspected plagiarism and inappropriate self-plagiarism will be referred to the Association’s Panel on Ethical Scientific Programs (ESP). Information on how such cases are addressed by the ESP can be found in the section below titled “Responses to Possible Scientific or Publishing Misconduct.” Digital Image Manipulation. ADA has adopted the statement developed by the Journal of Cell Biology [J

Cell Biol 166:11-15 (2004)] as its policy on the manipulation of digital images:

“No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. The grouping of images from different parts of the same gel, or from different gels, fields, or exposures must be made explicit by the arrangement of the figure (i.e., using dividing lines) and in the text of the figure legend. Adjustments of brightness, contrast, or color balance are acceptable if they are applied to the whole image [that is, every pixel] and as long as they do not obscure, eliminate, or misrepresent any information present in the original, including backgrounds. Without any background information, it is not possible to see exactly how much of the original gel is actually shown. Non-linear adjustments (e.g., changes to gamma settings) must be disclosed in the figure legend.” For presented blots, noncontiguous lanes may be spliced together only when the lanes were run on the same gel at the same time. This alteration should be made apparent in the presented figure by inserting a thin dividing line between the lanes, and it should be clearly explained and described in the figure legend.

At the revision stage, all authors are required to submit, together with the revised manuscript, a zip file titled "Source_Files.zip" that contains the original, uncropped and unedited photographs of all figures that represent gels, Western blots, microscopic photos, etc., intended to be published in the final version of the article, if accepted. Each gel/blot should be labeled as “Full unedited gel/blot for Figure X,” and the authors should highlight which lanes of the unedited gel/blot correspond to those shown in the cropped images presented in the manuscript. This zip file will be temporarily archived in the manuscript submission site if the paper is accepted; it will not be available to readers unless specifically requested by the authors to be published online. Failure to provide such original photographs will delay, or even preclude, publication of a manuscript in ADA journals.

Furthermore, all digital images in manuscripts accepted for publication will be scanned using image forensics software for any indication of improper manipulation. Cases of questionable or inappropriate image alterations will be referred to the Association’s Panel on Ethical Scientific Programs (ESP). The ESP may request the original data from the authors for comparison to the prepared figures. If the original data cannot be produced, the acceptance of the manuscript will be revoked. Cases of deliberate misrepresentation of data will result in revocation of acceptance, and will be reported to the corresponding author's home institution and/or funding agency as appropriate.

For examples of what constitutes improper digital manipulation (as well as other forms of scientific misconduct), ADA encourages authors to refer to the 2006 editorial by the Journal of Clinical Investigation titled “Stop Misbehaving!” [J Clin Invest 116:1740-1741 (2006)].

In addition, authors are encouraged to refer Adobe’s white paper on using Photoshop in biomedical imaging. The paper provides useful information on maintaining image integrity, editing nondestructively, and the medical and scientific image workflow.

Responses to Possible Scientific or Publishing Misconduct ADA journals are member journals of the Committee on Publication Ethics (COPE). COPE, established in 1997, is a charity registered in the U.K. The Committee is concerned with the integrity of peer-reviewed publications in science, particularly biomedicine.

In cases of possible scientific or publishing misconduct, ADA will consult COPE’s 17 flowcharts that provide algorithms for editors to follow when they suspect publication misconduct. Cases that cannot be properly addressed by use of COPE’s algorithms will be investigated and addressed by ADA’s Panel on Ethical Scientific Programs (ESP) on a case-by-case basis.

The ESP works on behalf of ADA scientific programs and publications to objectively and efficiently investigate cases of potential or perceived misconduct. The panel is comprised of expert independent investigators who share the Association’s vision for appropriateness in scientific procedures.

ADA and the ESP take seriously all reported concerns and allegations. When investigating and responding to cases of suspected misconduct, the panel operates with the utmost regard for the sensitivity, confidentiality, and impartiality required to fairly resolve each case.

The ESP strives to keep the number of inquiries and those involved to the minimum necessary to reach a recommendation for responding to the allegation.

In accordance with the recommendations of WAME, if the inquiry concludes there is a reasonable possibility of misconduct, responses will be contingent on the apparent magnitude of the misconduct.

Responses will depend on the circumstances of the case as well as the responses of the participating parties and institutions. To respond to each case, ADA will refer to COPE’s algorithms and the following options outlined by WAME, which have been slightly modified and are listed in approximate order of

severity:

 A letter of explanation (and education) sent only to the person against whom the complaint is made, where there appears to be a genuine and innocent misunderstanding of principles or procedure.

 A letter of reprimand to the same party, warning of the consequences of future such instances, where the misunderstanding appears to be not entirely innocent.

 A formal letter as above, including a written request to the supervising institution to carry out an investigation and report the findings of the investigation in writing to the journal. ADA will review and take into consideration the recommendations of investigating institutions when determining how to further respond to cases.



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