Ethical Issues in Biomedical Ethical Issues in Biomedical PublicationPublication

Arash Etemadi, MD PhDArash Etemadi, MD PhDDepartment of Epidemiology and Department of Epidemiology and

Biostatistics, School of Public Health, Biostatistics, School of Public Health, Tehran University of Medical SciencesTehran University of Medical Sciences

aetemadi@tums.ac.iraetemadi@tums.ac.ir

www.icmje.org

http://tumspress.tums.ac.irhttp://tumspress.tums.ac.ir

Study design and ethical approvalData analysisAuthorshipConflicts of interestPeer reviewRedundant publication (and duplicate submission)Plagiarism and fraudDealing with misconduct

Authorship/contributorshipAuthorship/contributorshipWho is an author? IWho is an author? I

A totally blind haphazard study of the effect of being left-handed on A totally blind haphazard study of the effect of being left-handed on promotion within medicinepromotion within medicine

A. A. Professor Sir Joshua FulloftoshProfessor Sir Joshua Fulloftosh, , president of the university. president of the university. Raised the grant, got permission for the study from the left-handed Raised the grant, got permission for the study from the left-handed societysociety

B. B. Professor Michael HalfpennyProfessor Michael Halfpenny, , British American Tobacco British American Tobacco professor in the joint department of respiratory, left-handedness, professor in the joint department of respiratory, left-handedness, and imaginary studies. and imaginary studies. Suggested the idea for the trial before Suggested the idea for the trial before departing for a six month sabbatical in the Seychelles and handled departing for a six month sabbatical in the Seychelles and handled the postpublication media coverage by satellitethe postpublication media coverage by satellite

Authorship/contributorshipAuthorship/contributorshipWho is an author? IIWho is an author? II

C. C. Dr Alec FedupDr Alec Fedup, , senior lecturer in the department of left-handed senior lecturer in the department of left-handed studies. studies. Drew up the protocol, wrote the grant proposal, and then Drew up the protocol, wrote the grant proposal, and then died in mysterious circumstances.died in mysterious circumstances.

D. D. Sir Bloated CorpulentSir Bloated Corpulent, , visiting consultant. visiting consultant. Allowed his staff to be Allowed his staff to be entered haphazardly into the studyentered haphazardly into the study

E. E. Dr Alice HolditalltogetherDr Alice Holditalltogether, , senior registrarsenior registrar. Ran the study, . Ran the study, collected the data and sent them to the statistician, arranged for the collected the data and sent them to the statistician, arranged for the writing up of the study, and negotiated with the editorswriting up of the study, and negotiated with the editors

Authorship/contributorshipAuthorship/contributorshipWho is an author? IIIWho is an author? III

F. F. Polly Paired-T-TestPolly Paired-T-Test, , statistician. statistician. Did all the analysis, prepared Did all the analysis, prepared the tablesthe tables

G. G. Pamela PoltergeistPamela Poltergeist, , editorial adviser to the left-handed people. editorial adviser to the left-handed people. Wrote the paperWrote the paper

E. E. Professor Avaricious LoadsapesetasProfessor Avaricious Loadsapesetas, , director of the Acapulco director of the Acapulco Institute of International left-handedness and Financial Studies. Institute of International left-handedness and Financial Studies. Allowed his name to be added to the paper in exchange for a Allowed his name to be added to the paper in exchange for a lucrative consultancy. Unfortunately didnlucrative consultancy. Unfortunately didn==t have time to read the t have time to read the paper.paper.

AuthorshipAuthorship

““For each individual the privilege of For each individual the privilege of authorship should be based on a authorship should be based on a significantsignificant contribution to the contribution to the conceptualization, design, execution, conceptualization, design, execution, and/or interpretation of the research study, and/or interpretation of the research study, as well as a willingness to assume as well as a willingness to assume responsibility for the study.”responsibility for the study.”

Guidelines for the Conduct of Research in the Intramural Research Programs at NIH. Guidelines for the Conduct of Research in the Intramural Research Programs at NIH. http://www.nih.gov/news/irnews/guidelines.htm#anchor128256

Authorship credit should be based onAuthorship credit should be based on– 1) substantial contributions to conception and 1) substantial contributions to conception and

design, or acquisition of data, or analysis and design, or acquisition of data, or analysis and interpretation of data; interpretation of data;

– 2) drafting the article or revising it critically for 2) drafting the article or revising it critically for important intellectual content; important intellectual content;

– and 3) final approval of the version to be and 3) final approval of the version to be published. published.

Authors should meet conditions 1, 2, and Authors should meet conditions 1, 2, and 3.3.

Acquisition of funding, collection of data, or general Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify supervision of the research group, alone, does not justify authorship.authorship.All persons designated as authors should qualify for All persons designated as authors should qualify for authorship, and all those who qualify should be listed.authorship, and all those who qualify should be listed.Each author should have participated sufficiently in the Each author should have participated sufficiently in the work to take public responsibility for appropriate portions work to take public responsibility for appropriate portions of the content. of the content. The order of authorship on the byline should be a joint The order of authorship on the byline should be a joint decision of the co-authors. Authors should be prepared decision of the co-authors. Authors should be prepared to explain the order in which authors are listed.to explain the order in which authors are listed.

All contributors who do not meet the criteria for All contributors who do not meet the criteria for authorship should be listed in an acknowledgments authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged section. Examples of those who might be acknowledged include a person who provided purely technical help, include a person who provided purely technical help, writing assistance, or a department chair who provided writing assistance, or a department chair who provided only general support. only general support. Financial and material support Financial and material support should also be acknowledged.should also be acknowledged. Groups of persons who have contributed materially to Groups of persons who have contributed materially to the paper but whose contributions do not justify the paper but whose contributions do not justify authorship may be listed under a heading such as authorship may be listed under a heading such as “clinical investigators” or “participating investigators” “clinical investigators” or “participating investigators”

When a large, multi-center group has When a large, multi-center group has conducted the work, the group should conducted the work, the group should identify the individuals who accept direct identify the individuals who accept direct responsibility for the manuscript. responsibility for the manuscript.

These individuals should fully meet the These individuals should fully meet the criteria for authorship defined above. criteria for authorship defined above.

An example: GEMINI

Authorship (Order)Authorship (Order)

Significance depends on fieldSignificance depends on field““First Author” a coveted position (second First Author” a coveted position (second author?)author?)Complicated by equal collaborationsComplicated by equal collaborationsNow most commonly:Now most commonly:

Janet DiMarci, Louis Hernandez, Arthur Smith, and Janet DiMarci, Louis Hernandez, Arthur Smith, and Wen ZhouWen Zhou

day to day responsibility

head of lab/PI

Conflicts of interestConflicts 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.

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

Redundant publication/ duplicate Redundant publication/ duplicate submissionsubmission

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.

Find 2 differences and win!Find 2 differences and win!

To be continued …To be continued …

(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.

What is fraud?What is fraud?

Fabrification: Invention of data or casesFabrification: Invention of data or cases

Falsification: Wilful distortion of dataFalsification: Wilful distortion of data– Ignoring outliers?Ignoring outliers?– Not admitting that some data are Not admitting that some data are

missing.missing.– Post hoc analyses that are not Post hoc analyses that are not

admitted?admitted?– Not including data on side effects in a Not including data on side effects in a

clinical trialclinical trial

What is fraud?What is fraud?

Plagiarism: Copying of data or papersPlagiarism: Copying of data or papers– But by how much?But by how much?– Stealing ideas?Stealing ideas?

Redundant publicationRedundant publication

Gift authorship.Gift authorship.

Not attributing other authors.Not attributing other authors.

Not publishing researchNot publishing research

Not disclosing a conflict of interestNot disclosing a conflict of interest

EtblastEtblast

Deja vuDeja vu

PlagiarismPlagiarism

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.

Serious misconduct

Less serious misconduct

Sanctions, blacklists