1. Ethical Issues in Biomedical Publication Arash Etemadi, MD PhD Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences aetemadi@tums.ac.ir

4. Study design and ethical approval Data analysis Authorship Conflicts of interest Peer review Redundant publication (and duplicate submission) Plagiarism and fraud Dealing with misconduct

5. Study design and ethical approval Data analysis Authorship Conflicts of interest Peer review Redundant publication (and duplicate submission) Plagiarism and fraud Dealing with misconduct

6. Authorship “For each individual the privilege of authorship should be based on a significant contribution to the conceptualization, design, execution, and/or interpretation of the research study, as well as a willingness to assume responsibility for the study.” Guidelines for the Conduct of Research in the Intramural Research Programs at NIH. http://www.nih.gov/news/irnews/guidelines.htm#anchor128256 http://www.nih.gov/news/irnews/guidelines.htm#anchor128256

8. 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. Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy, as well as a policy on identifying who is responsible for the integrity of the work as a whole (guarantorship).

9. Authorship/contributorship Who is an author? I A totally blind haphazard study of the effect of being left-handed on promotion within medicine A. Professor Sir Joshua Fulloftosh, president of the university. Raised the grant, got permission for the study from the left-handed society B. Professor Michael Halfpenny, British American Tobacco professor in the joint department of respiratory, left-handedness, and imaginary studies. Suggested the idea for the trial before departing for a six month sabbatical in the Seychelles and handled the postpublication media coverage by satellite

10. Authorship/contributorship Who is an author? II C. Dr Alec Fedup, senior lecturer in the department of left-handed studies. Drew up the protocol, wrote the grant proposal, and then died in mysterious circumstances. D. Sir Bloated Corpulent, visiting consultant. Allowed his staff to be entered haphazardly into the study E. Dr Alice Holditalltogether, senior registrar. Ran the study, collected the data and sent them to the statistician, arranged for the writing up of the study, and negotiated with the editors

11. Authorship/contributorship Who is an author? III F. Polly Paired-T-Test, statistician. Did all the analysis, prepared the tables G. Pamela Poltergeist, editorial adviser to the left-handed people. Wrote the paper E. Professor Avaricious Loadsapesetas, director of the Acapulco Institute of International left-handedness and Financial Studies. Allowed his name to be added to the paper in exchange for a lucrative consultancy. Unfortunately didn=t have time to read the paper.

12. Authorship credit should be based on –1) substantial contributions to conception and design, or 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.

13. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify 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. The order of authorship on the byline should be a joint decision of the co-authors. Authors should be prepared to explain the order in which authors are listed.

14. All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support. 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 a heading such as “clinical investigators” or “participating investigators”

15. When a large, multi-center 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. An example: GEMINI An example: GEMINI

16. Authorship (Order) Significance depends on field “First Author” a coveted position (second author?) Complicated by equal collaborations Now most commonly: Janet DiMarci, Louis Hernandez, Arthur Smith, and Wen Zhou day to day responsibility head of lab/PI

17. Conflicts of interest Conflicts of interest comprise those which may not be fully apparent and which may influence the judgment of author, reviewers, and editors. They have been described as those which, when revealed later, would make a reasonable reader feel misled or deceived. They may be personal, commercial, political, academic or financial. “Financial” interests may include employment, research funding, stock or share ownership, payment for lectures or travel, consultancies and company support for staff.

18. Competing interests: Tim Albert earns his living from running courses on effective writing skills.

19. Redundant publication/ duplicate submission Redundant publication occurs when two or more papers, without full cross reference, share the same hypothesis, data, discussion points, or conclusions. Duplicate submission is when the same manuscript has been sent to journal while still under evaluation by another.

20. (1) Published studies do not need to be repeated unless further confirmation is required. (2) Previous publication of an abstract during the proceedings of meetings does not preclude subsequent submission for publication, but full disclosure should be made at the time of submission. (3) Re-publication of a paper in another language is acceptable, provided that there is full and prominent disclosure of its original source at the time of submission. (4) At the time of submission, authors should disclose details of related papers, even if in a different language, and similar papers in press.

21. What is fraud? Fabrification: Invention of data or cases Falsification: Wilful distortion of data –Ignoring outliers? –Not admitting that some data are missing. –Post hoc analyses that are not admitted? –Not including data on side effects in a clinical trial

22. What is fraud? Plagiarism: Copying of data or papers –But by how much? –Stealing ideas? Redundant publication Gift authorship. Not attributing other authors. Not publishing research Not disclosing a conflict of interest

23. Plagiarism Plagiarism ranges from the unreferenced use of others’ published and unpublished ideas, including research grant applications to submission under “new” authorship of a complete paper, sometimes in a different language. It may occur at any stage of planning, research, writing, or publication: it applies to print and electronic versions. All sources should be disclosed, and if large amounts of other people’s written or illustrative material is to be used, permission must be sought.

24. Serious misconduct Less serious misconduct Sanctions, blacklists