Ethical Issues in Biomedical Publication

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Ethical Issues in Biomedical Publication

• Arash Etemadi, MD PhD
• Department of Epidemiology and Biostatistics,
  School of Public Health, Tehran University of
  Medical Sciences
• aetemadi_at_tums.ac.ir

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• www.icmje.org
• http//tumspress.tums.ac.ir

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

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Authorship/contributorshipWho 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

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Authorship/contributorshipWho 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

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Authorship/contributorshipWho 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 didnt
  have time to read the paper.

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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.htmanch
  or128256

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• 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.

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• 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.

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• 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

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• 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

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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
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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.

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

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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.

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Find 2 differences and win!
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To be continued
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• (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.

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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

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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

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• Etblast
• Deja vu

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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 peoples written or illustrative
  material is to be used, permission must be
  sought.

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• Serious misconduct
• Less serious misconduct
• Sanctions, blacklists