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Responsible research publication: international standards for authors

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1 Responsible research publication: international standards for authors
Ethical Considerations in the Conduct and Reporting of Research Supercourse, July 9-13, Ainur Akilzhanova M.D., Ph.D., D.M.Sc. All lectures from Workshop - This project is made possible by the support of the American people through the United States Agency for International Development (USAID). The contents are the sole responsibility of the University of Pittsburgh and do not necessarily reflect the views of USAID or the United States  Government. A small group of editors of general medical journals met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. This group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the National Library of Medicine (NLM), were first published in The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE has gradually broadened its concerns to include ethical principles related to publication in biomedical journals.

2 Scientific Knowledge The object of research is to extend human knowledge beyond what is already known. But an individual’s knowledge enters the domain of science only after it is presented to others in such a fashion that they can independently judge its validity (NAP, “On Being a Scientist” 1995)

3 Introduction Publication is the final stage of research and therefore a responsibility for all researchers. Scholarly publications are expected to provide a detailed and permanent record of research. Because publications form the basis for both new research and the application of findings, they can affect not only the research community but also, indirectly, society at large. Researchers therefore have a responsibility to ensure that their publications are honest, clear, accurate, complete and balanced, and should avoid misleading, selective or ambiguous reporting. Journal editors also have responsibilities for ensuring the integrity of the research literature and these are set out in companion guidelines. PUBLICATION OF A RESEARCH article represents the final stage of a scientific project. It is the culmination of many months and sometimes years of meticulous planning, execution, and analyses of hundreds of experiments. In many cases, the funds supporting the project were derived from public monies. There is, therefore, the expectation that the work be conducted and reported honestly, objectively, and fairly. Yet, sometimes deviations from this ideal occur. Ethical breaches can be intentional, such as data fabrication, or can arise simply out of ignorance, e.g., inappropriate anesthetic use in animal experimentation. Nonetheless, in legal parlance, ignorance is not and cannot be an excuse. Thus it is incumbent on every investigator to be cognizant of all the ethical requirements for conducting scientific studies. Moreover, a scientist needs to develop a strong sense of ethical responsibility to apply at every stage of scientific inquiry. Straying from an ethical course during the conduct of an investigation undoubtedly manifests itself during the publication phase.

4 Publication Publication of results is an integral and essential component of research. The University encourages all researchers to promote their work through publishing and other forms of dissemination. Flow diagram of review and publication process for a manuscript submitted to a journal Publishing includes: publishing in peer-reviewed journals and books publishing in non peer-reviewed journals conference presentations (peer-reviewed and non peer-reviewed) and/or published in proceedings posters presented at conferences reports commissioned by external organisations promotional reports and materials on research articles in the popular press and other media publication in web-based journals and project web sites Dale J. Benos, Jorge Fabres, John Farmer, et al Ethics and scientific publication// Adv Physiol Educ 29: 59–74, 2005

5 What is publishable…. Journals like to publish papers that are going to be widely read and useful to the readers Papers that report “original and significant” findings that are likely to be of interest to a broad spectrum of its readers Papers that are well organized and well written, with clear statements regarding how the findings relate to and advance the understanding/development of the subject Papers that are concise and yet complete in their presentation of the findings

6 Distribution of ethical issues in American Physiological Society publications (1996 through March 2004) Dale J. Benos, Jorge Fabres, John Farmer, et al Ethics and scientific publication// Adv Physiol Educ 29: 59–74, 2005

7 Authorship and Contributorship
An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study, and biomedical authorship continues to have important academic, social, and financial implications .  Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3. Being an author on a scientific manuscript is a privilege and one of the more satisfying experiences of a scientist. Acquisition of funding, collection of data, 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. 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/contributorship defined above, and editors will ask these individuals to complete journal-specific author and conflict-of-interest disclosure forms. 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.

8 Authorship guest authors are those who do not meet accepted authorship criteria but are listed because of their seniority, reputation or supposed influence gift authors are those who do not meet accepted authorship criteria but are listed as a personal favour or in return for payment ghost authors are those who meet authorship criteria but are not listed

9 Authorship A: average number of authors per article
published in the research journals of APS from 1960–2004. B: percentage of the total number of published articles in the American Journal of Physiology-Consolidated (AJP), Journal of Applied Physiology (JAP), and Journal of Neurophysiology (JN) authored by either one (OE) or two (■) persons from 1960–2004. Dale J. Benos, Jorge Fabres, John Farmer, et al Ethics and scientific publication// Adv Physiol Educ 29: 59–74, 2005

10 Contributors Listed in Acknowledgments
All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Editors should ask corresponding authors to declare whether they had assistance with study design, data collection, data analysis, or manuscript preparation. If such assistance was available, the authors should disclose the identity of the individuals who provided this assistance and the entity that supported it in the published article. Financial and material support should also be acknowledged. Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may be listed under such headings as “clinical investigators” or “participating investigators,” and their function or contribution should be described—for example, “served as scientific advisors,” “critically reviewed the study proposal,” “collected data,” or “provided and cared for study patients.” Because readers may infer their endorsement of the data and conclusions, these persons must give written permission to be acknowledged. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chairperson who provided only general support.

11 Sample authorship description/acknowledgement
Drs A, B and C designed and conducted the study, including patient recruitment, data collection, and data analysis. Dr A prepared the manuscript draft with important intellectual input from Drs B and C. All authors approved the final manuscript. [Insert name of organization] provided funding for the study, statistical support in analyzing the data with input from Drs A, B and C, and also provided funding for editorial support. Drs A, B and C had complete access to the study data. We would like to thank Dr D for her editorial support during preparation of this manuscript.

12 Accountability and responsibility
All authors should have read and be familiar with the reported work and should ensure that publications follow the principles set out in these guidelines. In most cases, authors will be expected to take joint responsibility for the integrity of the research and its reporting. However, if authors take responsibility only for certain aspects of the research and its reporting, this should be specified in the publication. Authors should work with the editor or publisher to correct their work promptly if errors or omissions are discovered after publication. Authors should abide by relevant conventions, requirements, and regulations to make materials, reagents, software or datasets available to other researchers who request them. Researchers, institutions, and funders should have clear policies for handling such requests. Authors must also follow relevant journal standards. While proper acknowledgement is expected, researchers should not demand authorship as a condition for sharing materials. Authors should respond appropriately to post-publication comments and published correspondence. They should attempt to answer correspondents’ questions and supply clarification or additional details where needed.

13 Soundness and reliability
The research being reported should have been conducted in an ethical and responsible manner and follow all relevant legislation. The research being reported should be sound and carefully executed. Researchers should use appropriate methods of data analysis and display (and, if needed, seek and follow specialist advice on this). Authors should take collective responsibility for their work and for the content of their publications. Researchers should check their publications carefully at all stages to ensure methods and findings are reported accurately. Authors should carefully check calculations, data presentations, typescripts/submissions and proofs.

14 Useful Definitions: Scientific Misconduct
“Scientific misconduct means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research” Managing Allegations of Scientific Misconduct: A Guidance Document for Editors, January 2000, Office of Research Integrity, Office of Public Health and Science, U.S. Dept. of Health and Human Services

15 Useful Definitions: Plagiarism: using the ideas or words of another person without giving appropriate credit (Nat. Acad. Press document) Self-Plagiarism: The verbatim copying or reuse of one’s own research (IEEE Policy statement) Both types of plagiarism are considered to be unacceptable practice by most scientific publications

16 Honesty Researchers should present their results honestly and without fabrication, falsification or inappropriate data manipulation. Research images (e.g. micrographs, X- rays, pictures of electrophoresis gels) should not be modified in a misleading way. Researchers should strive to describe their methods and to present their findings clearly and unambiguously. Researchers should follow applicable reporting guidelines. Publications should provide sufficient detail to permit experiments to be repeated by other researchers. Reports of research should be complete. They should not omit inconvenient, inconsistent or inexplicable findings or results that do not support the authors’ or sponsors’ hypothesis or interpretation. Research funders and sponsors should not be able to veto publication of findings that do not favour their product or position. Researchers should not enter agreements that permit the research sponsor to veto or control the publication of the findings (unless there are exceptional circumstances, such as research classified by governments because of security implications). Authors should alert the editor promptly if they discover an error in any submitted, accepted or published work. Authors should cooperate with editors in issuing corrections or retractions when required. Authors should represent the work of others accurately in citations and quotations. Authors should not copy references from other publications if they have not read the cited work.

17 Intellectual Property Plagiarism, copyright and intellectual property
A definition of plagiarism from the Office of Research Integrity: Plagiarism includes both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review. All Authors are required to grant editors an exclusive publishing license before their work can be published. This license also contains the warranty that the work is the author’s original work.

18 Original paper: Ultra-large-scale syntheses of monodisperse nanocrystals, Park et al. Nature Materials, 2004, 3, 891 (Figure 3C) Original Paper Oriented Assembly of Fe3O4 Nanoparticles into Monodisperse Hollow Single-Crystal Microspheres Yu et al, J. Phys. Chem. B 2006, 110, (Figure 3) Plagiarized paper: Fabrication of Monodisperse Magnetic Fe3O4-SiO2 Nanocomposites with Core-Shell Structures Hua Fang,* Chun-yang Ma, Tai-li Wan, Mei Zhang, and Wei-hai Shi J. Phys. Chem C 2007, 111,

19 Credit Citing sources of information and ideas (also aids credibility, helps in finding out more) Avoiding excessive use of others’ words Recording sources when copying items or taking notes Placing in quotation marks, or indenting, items used verbatim Perhaps drafting some items while not looking at the source materials Observing copyright and obtaining needed permissions

20 24 MAY 2002 VOL 296 SCIENCE, p 1376

21 Other Types of Ethical Violations
Duplicate publication/submission of research findings; failure to inform the editor of related papers that the author has under consideration or “in press” Unrevealed conflicts of interest that could affect the interpretation of the findings Misrepresentation of research findings - use of selective or fraudulent data to support a hypothesis or claim

22 Originality Not republishing the same findings (except under special circumstances, with the original source cited) Not submitting the same manuscript to two or more journals at once Not dividing one research project into many little papers (“salami science”) Authors should adhere to publication requirements that submitted work is original and has not been published elsewhere in any language. Work should not be submitted concurrently to more than one publication unless the editors have agreed to co-publication. If articles are co-published this fact should be made clear to readers. Applicable copyright laws and conventions should be followed. Copyright material (e.g. tables, figures or extensive quotations) should be reproduced only with appropriate permission and acknowledgement. Relevant previous work and publications, both by other researchers and the authors’ own, should be properly acknowledged and referenced. The primary literature should be cited where possible. Data, text, figures or ideas originated by other researchers should be properly acknowledged and should not be resented as if they were the authors’ own. Original wording taken directly from publications by other researchers should appear in quotation marks with the appropriate citations. Authors should inform editors if findings have been published previously or if multiple reports or multiple analyses of a single data set are under consideration for publication elsewhere. Authors should provide copies of related publications or work submitted to other journals. Multiple publications arising from a single research project should be clearly identified as such and the primary publication should be referenced. Translations and adaptations for different audiences should be clearly identified as such, should acknowledge the original source, and should respect relevant copyright conventions and permission requirements. If in doubt, authors should seek permission from the original publisher before republishing any work.

23 Balance New findings should be presented in the context of previous research. The work of others should be fairly represented. Scholarly reviews and syntheses of existing research should be complete, balanced, and should include findings regardless of whether they support the hypothesis or interpretation being proposed. Editorials or opinion pieces presenting a single viewpoint or argument should be clearly distinguished from scholarly reviews. Study limitations should be addressed in publications.

24 Transparency All sources of research funding, including direct and indirect financial support, supply of equipment or materials, and other support (such as specialist statistical or writing assistance) should be disclosed. Authors should disclose the role of the research funder(s) or sponsor (if any) in the research design, execution, analysis, interpretation and reporting. Authors should disclose relevant financial and non-financial interests and relationships that might be considered likely to affect the interpretation of their findings or which editors, reviewers or readers might reasonably wish to know. This includes any relationship to the journal, for example if editors publish their own research in their own journal. In addition, authors should follow journal and institutional requirements for disclosing competing interests.

25 Adherence to peer review and publication conventions
Authors should follow publishers’ requirements that work is not submitted to more than one publication for consideration at the same time. Authors should inform the editor if they withdraw their work from review, or choose not to respond to reviewer comments after receiving a conditional acceptance. Authors should respond to reviewers’ comments in a professional and timely manner. Authors should respect publishers’ requests for press embargos and should not generally allow their findings to be reported in the press if they have been accepted for publication (but not yet published) in a scholarly publication. Authors and their institutions should liaise and cooperate with publishers to coordinate media activity (e.g. press releases and press conferences) around publication. Press releases should accurately reflect the work and should not include statements that go further than the research findings.

26 Ethical principles: Research on Humans and Animals
For experiments involving human subjects, the committee approving the experiments should be identified and the research conducted according to the principles expressed in the Declaration of Helsinki). The Authors should confirm that informed consent was obtained from all subjects. Appropriate approval, licensing or registration should be obtained before the research begins and details should be provided in the report (e.g. Institutional Review Board, Research Ethics Committee approval, national licensing authorities for the use of animals) Treatment must confirm to accepted international standards. Manuscript must document that the study was approved by an ethical review board before it was done. Note: Research on humans tends to be broadly defined, for example to include survey research. Declaration of Helsinki

27 Ethical responsibilities of Editors and reviewers
Maintain confidentiality Not to misappropriate ideas or text Emit reviews that are justifiable and without bias Transmit information to authors in a timely fashion Declare any conflict of interest

28 Peer Review Unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Peer review helps editors decide which manuscripts are suitable for their journals and helps authors and editors to improve the quality of reporting. A peer-reviewed journal submits most of its published research articles for outside review. The number and kinds of manuscripts sent for review, the number of reviewers, the reviewing procedures, and the use made of the reviewers’ opinions may vary.

29 Conflicts of Interest Editors, authors, and peer reviewers have a responsibility to disclose interests that might appear to affect their ability to present or review data objectively. These include relevant financial (for example patent ownership, stock ownership, consultancies, speaker's fees), personal, political, intellectual, or religious interests. Can involve Editors Peer reviewers Authors Can be Financial Ideological Other Potential Conflicts of Interest Related to Project Support Increasingly, individual studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias and otherwise discredit the research. Scientists have an ethical obligation to submit creditable research results for publication. Researchers should not enter into agreements that interfere with their access to all of the data and their ability to analyze them independently, and to prepare and publish manuscripts. Authors should describe the role of the study sponsor, if any, in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. Editors should be encouraged to review copies of the protocol and/or contracts associated with project-specific studies before accepting such studies for publication. Editors may request a statistical analysis of all data by an independent biostatistician. Editors may choose not to consider an article if a sponsor has asserted control over the authors’ right to publish. Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from being negligible to having great potential for influencing judgment. Not all relationships represent true conflict of interest. On the other hand, the potential for conflict of interest can exist regardless of whether an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion. Editors may use information disclosed in conflict-of-interest and financial-interest statements as a basis for editorial decisions. Editors should publish this information if they believe it is important in judging the manuscript.

30 Summary The research being reported should have been conducted in an ethical and responsible manner and should comply with all relevant legislation. Researchers should present their results clearly, honestly, and without fabrication, falsification or inappropriate data manipulation. Researchers should strive to describe their methods clearly and unambiguously so that their findings can be confirmed by others. Researchers should adhere to publication requirements that submitted work is original, is not plagiarised, and has not been published elsewhere. Authors should take collective responsibility for submitted and published work. The authorship of research publications should accurately reflect individuals’ contributions to the work and its reporting. Funding sources and relevant conflicts of interest should be disclosed.

31 How Journals Detect and Handle Problem Papers
Information received from reviewers or other editors Literature search for related papers by the author Withdrawal of a paper from publication Banning authors from publication in the journal for 3-5 years and informing the co-authors and editors of related journals of our action For less serious cases, placing the author on a “watch list” for careful examination of their submissions prior to requesting review

32 International guidelines
International Committee of Medical Journal Editors (ICMJE). Includes guidelines for authorship (substantive), peer review (not substantive), conflict of interest (substantive), and redundant publications (substantive). The Committee on Publication Ethics (COPE) has guidelines for editors and peer reviewers (substantive) and authorship (substantive). The Singapore Statement on Research Integrity also has guidelines on authorship, publication, and peer review. These are very general, not detailed. Scott-Lichter D, and the Editorial Policy Committee, Council of Science Editors. CSE’s White Paper on Promoting Integrity in Scientific Journal Publications. Reston, Virginia, USA: CSE; On Being a Scientist: Responsible Conduct in Research, 2nd edition (1995): From the US National Academies Largely for graduate students World Association of Medical Editors (WAME): International Committee of Medical Journal Editors (ICMJE). Includes guidelines for authorship (substantive), peer review (not substantive), conflict of interest (substantive), and redundant publications (substantive). The Committee on Publication Ethics (COPE) has guidelines for editors and peer reviewers (substantive) and authorship (substantive). The Singapore Statement on Research Integrity also has guidelines on authorship, publication, and peer review. These are very general, not detailed. Scott-Lichter D, and the Editorial Policy Committee, Council of Science Editors. CSE’s White Paper on Promoting Integrity in Scientific Journal Publications. Reston, Virginia, USA: CSE; On Being a Scientist: Responsible Conduct in Research, 2nd edition (1995): From the US National Academies Largely for graduate students World Association of Medical Editors (WAME):

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